• 23
  • February
  • 23
  • Friday
10:00 AM PST | 01:00 PM EST

Excel - Lists and Tables - A Beginner's Guide to Managing List-Based Data

Often perceived as a mere number-crunching tool, Excel's true prowess lies in its capacity to organize and manage list-based data efficiently and this training session is designed to unveil Excel's full potential beyond arithmetic computations.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 26
  • February
  • 26
  • Monday
09:00 AM PST | 12:00 PM EST

3-Hour Virtual Seminar on IQ, OQ, and PQ in the Verification and Validation Process

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You'll learn about what processes need to be validated and what steps you need to take to validate processes.

Susanne Manz Susanne Manz | Duration: 3 Hours | Price: $299.00 | View Details
  • 26
  • February
  • 26
  • Monday
10:00 AM PST | 01:00 PM EST

How to Deal With Bad Results Under GLP

Assessment of the cause for a non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 26
  • February
  • 26
  • Monday
10:00 AM PST | 01:00 PM EST

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Mike Thomas Mike Thomas | Duration: 90 Minutes | Price: $149.00 | View Details
  • 27
  • February
  • 27
  • Tuesday
10:00 AM PST | 01:00 PM EST

Using a Learning Management System (LMS) to Develop Pharma Training Curricula

Learning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training, and their GMP compliance, up to date. They often boast great functionality but also have limitations that must be overcome for a Pharma company to use them effectively.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 27
  • February
  • 27
  • Tuesday
10:00 AM PST | 01:00 PM EST

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 27
  • February
  • 27
  • Tuesday
10:00 AM PST | 01:00 PM EST

AI for Excel: Empowering Excel with ChatGPT and other AI Tools

In this webinar, we take an in-depth exploration of how AI, particularly ChatGPT, can revolutionize Excel usage and go beyond traditional spreadsheet functionalities. Attendees will gain valuable insights into the following key topics:

Alan Murray Alan Murray | Duration: 90 Minutes | Price: $149.00 | View Details
  • 28
  • February
  • 28
  • Wednesday
10:00 AM PST | 01:00 PM EST

Performance of Root Cause Analysis, CAPA, and Effectiveness Checks

This comprehensive course offers essential knowledge and practical skills in root cause analysis, corrective and preventive actions (CAPA), and conducting effectiveness checks.

Meredith Crabtree Meredith Crabtree | Duration: 90 Minutes | Price: $149.00 | View Details
  • 28
  • February
  • 28
  • Wednesday
10:00 AM PST | 01:00 PM EST

Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 28
  • February
  • 28
  • Wednesday
09:00 AM PST | 12:00 PM EST

Utilizing an Enhanced Free Clickable DMAIC Lean Six Sigma Roadmap so that Process Improvement Projects Benefit the Organization's Financials

Integrated Enterprise Excellence (IEE) provides a 9-step system for operational excellence (OE) that moves organizations toward achieving the 3R of business (i.e., everyone doing the Right things and doing them Right at the Right time).

Forrest Breyfogle Forrest Breyfogle | Duration: 90 Minutes | Price: $149.00 | View Details
  • 28
  • February
  • 28
  • Wednesday
10:00 AM PST | 01:00 PM EST

Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View Details
  • 28
  • February
  • 28
  • Wednesday
09:00 AM PST | 12:00 PM EST

Quality 4.0: Managing Disruptive Change

The feeling is sometimes created that technology itself leads the waves of change.

Willy Vandenbrande Willy Vandenbrande | Duration: 75 Minutes | Price: $149.00 | View Details
  • 28
  • February
  • 28
  • Wednesday
10:00 AM PST | 01:00 PM EST

Project Management For Non-Project Managers - How To Communicate Project Actions And Progress - Conducting Effective Project Review Meetings

This webinar is about effective communication inside and outside of the project team. The webinar will use case studies and examples to reinforce key teaching points. Instruction will begin with a discussion of the communication model and the barriers that can erect obstacles to understanding the information and intent of the communications sent and received.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 28
  • February
  • 28
  • Wednesday
09:00 AM PST | 12:00 PM EST

The Importance Of Training Compliance Officers

Since Compliance Officers have direct contact with all parts of the business, it’s essential that they have the necessary tools to succeed and help shift the compliance culture of an organization. This webinar is geared towards Compliance Officers in an organization that deal with internal stakeholders. We will discuss ways to train compliances officers effectively and how to go about it.

Justin Muscolino Justin Muscolino | Duration: 60 Minutes | Price: $149.00 | View Details
  • 29
  • February
  • 29
  • Thursday
10:00 AM PST | 01:00 PM EST

Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats

This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 29
  • February
  • 29
  • Thursday
10:00 AM PST | 01:00 PM EST

Validation of Artificial Intelligence (AI), Machine Language (ML), and other Superintelligence-Based Systems Regulated by FDA

During the webinar, we will discuss FDA’s considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee. You’ll also learn about current and potential uses of AI in health care and the challenges posed. We’ll cover how and under what circumstances products relying on AI are regulated by FDA, and how to ensure benefits of products outweigh risks.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 29
  • February
  • 29
  • Thursday
11:30 AM PST | 02:30 PM EST

Excel Vital Introductory Essentials with Tips & Shortcuts

This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $149.00 | View Details
  • 1
  • March
  • 01
  • Friday
08:00 AM PST | 11:00 AM EST

4-Hour Virtual Seminar on Combination Product Device Supplier Management Training

There has been a major shift in the emphasis of U.S. FDA requirements for supplier CGMP compliance.

John E Lincoln John E Lincoln | Duration: 4 Hours | Price: $445.00 | View Details
  • 1
  • March
  • 01
  • Friday
10:00 AM PST | 01:00 PM EST

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 1
  • March
  • 01
  • Friday
10:00 AM PST | 01:00 PM EST

Outlook - Master your Mailbox - Inbox Hero Inbox Zero

For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 1
  • March
  • 01
  • Friday
11:30 AM PST | 02:30 PM EST

Excel PivotTable Essentials for Data Management

PivotTables are reputed to be the most powerful “in-built” feature in Excel aside from Macros.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $149.00 | View Details
  • 1
  • March
  • 01
  • Friday
10:00 AM PST | 01:00 PM EST

US Market Access & Reimbursement; Medical Devices

This targeted 60-minute U.S. Reimbursement training/webinar will help you understand and navigate the complex U.S. system for understanding product reimbursement status and potential for your Medical Device.

Robert J. Russell Robert J. Russell | Duration: 60 Minutes | Price: $149.00 | View Details
  • 4
  • March
  • 04
  • Monday
10:00 AM PST | 01:00 PM EST

Understanding the Mindset of an FDA Employee

During this webinar we will provide information on the backgrounds of FDA employees, how FDA employees are trained, how they interact with the regulated industry.

Larry Stevens Larry Stevens | Duration: 60 Minutes | Price: $149.00 | View Details
  • 4
  • March
  • 04
  • Monday
10:00 AM PST | 01:00 PM EST

US, EU, Japan GMP Requirements

This ICH GMP 90-minute webinar will provide your company the opportunity for comprehensive understanding of ICH Drug / Biologic GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan).

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View Details
  • 4
  • March
  • 04
  • Monday
10:00 AM PST | 01:00 PM EST

Excel - Power Query - No Code Automation Every User Needs to Know About

Turn bad data into great data in minutes!

Mike Thomas Mike Thomas | Duration: 90 Minutes | Price: $149.00 | View Details
  • 5
  • March
  • 05
  • Tuesday
10:00 AM PST | 01:00 PM EST

GDP in Life Sciences - A Writing Perspective

Good Documentation Practices (GDP) in Life Sciences - A Writing Perspective is a pivotal exploration into the meticulous world of documentation within the dynamic field of life sciences.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 5
  • March
  • 05
  • Tuesday
12:00 PM PST | 03:00 PM EST

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 5
  • March
  • 05
  • Tuesday
10:00 AM PST | 01:00 PM EST

Secrets to Writing Effective SOPs for Medical Device QMS

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $149.00 | View Details
  • 5
  • March
  • 05
  • Tuesday
10:00 AM PST | 01:00 PM EST

How to Write SOPs for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 6
  • March
  • 06
  • Wednesday
08:00 AM PST | 11:00 AM EST

6-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.

Robert J. Russell Robert J. Russell | Duration: 6 Hours | Price: $545.00 | View Details
  • 6
  • March
  • 06
  • Wednesday
10:00 AM PST | 01:00 PM EST

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.

Dennis Taylor Dennis Taylor | Duration: 2 Hours | Price: $199.00 | View Details
  • 6
  • March
  • 06
  • Wednesday
11:30 AM PST | 02:30 PM EST

Excel Linking Techniques with Word PowerPoint Access & Web

Understand and apply the power of linking techniques within Excel and other key MS Office applications to boost productivity and efficiency for you and your organization.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $149.00 | View Details
  • 6
  • March
  • 06
  • Wednesday
09:00 AM PST | 12:00 PM EST

How To Enhance The Culture Of Compliance

People underestimate what a positive compliance culture can do for an organization. During this webinar, we will not discuss what happens when financial institutions get it wrong, but also, what happens when they get it right. Along with doing your own needs analysis and creating a necessary plan.

Justin Muscolino Justin Muscolino | Duration: 60 Minutes | Price: $149.00 | View Details
  • 6
  • March
  • 06
  • Wednesday
10:00 AM PST | 01:00 PM EST

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 6
  • March
  • 06
  • Wednesday
09:00 AM PST | 12:00 PM EST

Beyond ESG Compliance: Quality for a Sustainable Future

As a consequence, companies look at their IT department thinking that digitization will make the company better and more competitive. But the key to success is to use the right technology at the right time and in the right way.

Willy Vandenbrande Willy Vandenbrande | Duration: 75 Minutes | Price: $149.00 | View Details
  • 6
  • March
  • 06
  • Wednesday
10:00 AM PST | 01:00 PM EST

The Identification and Quantitation of Low-Level Compounds for Impurity and Degradation Analyses

Low-level compound analysis has many differences from that of the more common analyses aimed at major components.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 7
  • March
  • 07
  • Thursday
08:00 AM PST | 11:00 AM EST

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.

Carolyn Troiano Carolyn Troiano | Duration: 6 Hours | Price: $545.00 | View Details
  • 7
  • March
  • 07
  • Thursday
10:00 AM PST | 01:00 PM EST

SOPs for Virtual Companies - What You Need and What You Don't

Many virtual companies incorrectly think they don't need SOPs or GMP training.

Arvilla Trag Arvilla Trag | Duration: 60 Minutes | Price: $149.00 | View Details
  • 7
  • March
  • 07
  • Thursday
10:00 AM PST | 01:00 PM EST

Excel - A Beginner's Guide to Creating Effective Charts

Impress your boss. Impress your colleagues. Turn drab into fab. Tell your story with awesome charts in Excel. This webinar will equip you with the knowledge you need to turn your numerical data into a set of engaging, attention-grabbing and easy-to-understand visuals!

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 8
  • March
  • 08
  • Friday
08:00 AM PST | 11:00 AM EST

4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot

In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.

Tom Fragale Tom Fragale | Duration: 4 Hours | Price: $445.00 | View Details
  • 8
  • March
  • 08
  • Friday
10:00 AM PST | 01:00 PM EST

Writing for Regulatory Success - Strategies for Quality Technical Documents

This 90-minute webinar is designed to provide professionals across various industries with a comprehensive understanding of the critical intersection between effective technical writing, regulatory compliance, and copyright considerations.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 8
  • March
  • 08
  • Friday
10:00 AM PST | 01:00 PM EST

Vendor Audit - Focus on Cloud, Software-as-a-Service (SaaS), and Other Technologies used for FDA-Regulated Activities

We will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 8
  • March
  • 08
  • Friday
11:30 AM PST | 02:30 PM EST

PowerPoint Creating & Presenting a Complete Slide Show

From animations and video, through to organisation charts and process flows, PowerPoint is your complete presentation graphics package providing everything you need for communicating information in an engaging and professional format.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $149.00 | View Details
  • 8
  • March
  • 08
  • Friday
10:00 AM PST | 01:00 PM EST

China Regulatory Compliance for Life Sciences

China's Life Sciences Compliance webinar will discuss the regulatory structure and requirements for compliance against China's NMPA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View Details
  • 8
  • March
  • 08
  • Friday
10:00 AM PST | 01:00 PM EST

The New US FDA 21 CFR 820, Quality Management System Regulation (QMSR), Medical Device CGMPs

This webinar will discuss what the new QMSR will require. A key element is the incorporation of ISO 13485 into the new 820 by reference. Major emphasis will be upon risk management in accordance with ISO 14971 (-:2019), which currently has only casual reference in 820.30. The FDA views risk management as an “essential systematic practice” to ensure that devices are safe and effective. If the proposed rule is finalized, it will enhance some parts of ISO 13485. Device manufacturers will need to enhance risk management procedures for specific devices and in all other areas of their businesses to align with the QMSR. Design Control (ISO 13485 7.3 Design and Development) will have limited application to Class I devices, but fully involve Class II and III (US classifications) as is currently done in the US but not the EU.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 11
  • March
  • 11
  • Monday
10:00 AM PDT | 01:00 PM EDT

Device Changes, FDA Changes, and the 510(k)

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View Details
  • 11
  • March
  • 11
  • Monday
10:00 AM PDT | 01:00 PM EDT

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.

Mike Thomas Mike Thomas | Duration: 3 Hours | Price: $299.00 | View Details
  • 11
  • March
  • 11
  • Monday
10:00 AM PDT | 01:00 PM EDT

Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 12
  • March
  • 12
  • Tuesday
09:00 AM PDT | 12:00 PM EDT

3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

Carolyn Troiano Carolyn Troiano | Duration: 3 Hours | Price: $299.00 | View Details
  • 12
  • March
  • 12
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Scientific Writing Fundamentals - Mastering the Basics in Life Sciences Documentation

Scientific Writing Fundamentals - Mastering the Basics in Life Sciences Documentation is a dynamic and comprehensive 90-minute webinar designed to empower researchers, students, and professionals in the life sciences field with essential skills for effective written communication.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 12
  • March
  • 12
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

How to Prepare for and Host an FDA Inspection and respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 13
  • March
  • 13
  • Wednesday
11:00 AM PDT | 02:00 PM EDT

Understanding the Incredible Uses and Fallbacks of ChatGPT

ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.

Justin Muscolino Justin Muscolino | Duration: 60 Minutes | Price: $149.00 | View Details
  • 13
  • March
  • 13
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Excel Formulas and Functions

Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

Dennis Taylor Dennis Taylor | Duration: 60 Minutes | Price: $149.00 | View Details
  • 13
  • March
  • 13
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

The Transfer of Validated Methods

This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 13
  • March
  • 13
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $149.00 | View Details
  • 13
  • March
  • 13
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification

This 2-Hour Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls.

David Nettleton David Nettleton | Duration: 2 Hours | Price: $199.00 | View Details
  • 14
  • March
  • 14
  • Thursday
10:00 AM PDT | 01:00 PM EDT

SOPs - How to Write Them to Satisfy Those Inspectors

Attending this training will help the participant understand the specific requirements and expectations of FDA inspectors, allowing them to develop SOPs that meet regulatory standards and demonstrate compliance.

Meredith Crabtree Meredith Crabtree | Duration: 90 Minutes | Price: $149.00 | View Details
  • 14
  • March
  • 14
  • Thursday
11:30 AM PDT | 02:30 PM EDT

Excel Formulas Functions & Automatic Calculation Made Easy

Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $149.00 | View Details
  • 15
  • March
  • 15
  • Friday
08:00 AM PDT | 11:00 AM EDT

4-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.

Tom Fragale Tom Fragale | Duration: 4 Hours | Price: $445.00 | View Details
  • 18
  • March
  • 18
  • Monday
08:00 AM PDT | 11:00 AM EDT

How Accountants Can Use Chat GPT Effectively

ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.

Justin Muscolino Justin Muscolino | Duration: 60 Minutes | Price: $149.00 | View Details
  • 18
  • March
  • 18
  • Monday
10:00 AM PDT | 01:00 PM EDT

Excel - Creating an Interactive Dashboard

No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, its flexibility, and the fact that most people have it installed on their computers.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 19
  • March
  • 19
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 19
  • March
  • 19
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Responsibility for Off-Label Claims in Social Media

FDA's sweeping definition of labeling includes what is said or represented, even by images, on a social media platform.

Casper Uldriks Casper Uldriks | Duration: 60 Minutes | Price: $149.00 | View Details
  • 19
  • March
  • 19
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on Project Management for Non-Project Managers

What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant. You are half listening to the presentation while thinking about some of the other work you need to complete on different matters. The installation will take a year to execute and will require the coordination with several functions inside and outside of the company.

Charles H. Paul Charles H. Paul | Duration: 6 Hours | Price: $545.00 | View Details
  • 19
  • March
  • 19
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Medical Device Cybersecurity - FDA Guidance for Quality System Considerations and Content of Premarket Submissions

This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could result in injury or death to a patient or consumer. A serious threat, it must be dealt with at all levels to make sure the end product being used by a patient or consumer is perfectly safe and delivers the effective treatment required

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 19
  • March
  • 19
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Medical Device Software Validation Meeting FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 20
  • March
  • 20
  • Wednesday
08:00 AM PDT | 11:00 AM EDT

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.

Carolyn Troiano Carolyn Troiano | Duration: 4 Hours | Price: $445.00 | View Details
  • 20
  • March
  • 20
  • Wednesday
12:00 PM PDT | 03:00 PM EDT

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 20
  • March
  • 20
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Mastering Excel Pivot Tables

Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.

Dennis Taylor Dennis Taylor | Duration: 60 Minutes | Price: $149.00 | View Details
  • 20
  • March
  • 20
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 20
  • March
  • 20
  • Wednesday
11:30 AM PDT | 02:30 PM EDT

Project Essentials of Setup Calendars Tasks Scheduling & WBS

Plan and initiate your projects with confidence, knowledge and consistency.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $149.00 | View Details
  • 20
  • March
  • 20
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $149.00 | View Details
  • 20
  • March
  • 20
  • Wednesday
09:00 AM PDT | 12:00 PM EDT

The Missing Link; The Quality of Front-End Services

Services make up some 75% of the overall economic activity. But this economic reality is not visible in quality management. Members of quality organizations are mainly from manufacturing, the language we use is production related and our tools are to a large extend directed at solving technical problems.

Willy Vandenbrande Willy Vandenbrande | Duration: 60 Minutes | Price: $149.00 | View Details
  • 21
  • March
  • 21
  • Thursday
10:00 AM PDT | 01:00 PM EDT

The Human Error Toolbox: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 21
  • March
  • 21
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Reconciling/Adapting the 8D Problem-Solving Process with ISO regulations and 21CFR 820

This webinar will begin with an explanation of the process and how it originally conflicted with all regulatory bodies worldwide and how it now can be applied, with minor adjustments, to counter those original difficulties. The webinar will also discuss when the process should be used, how it should be staffed, and the process for its use.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 21
  • March
  • 21
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Medical Device Hazard analysis following ISO 14971

The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post-production risk management program to be implemented.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 21
  • March
  • 21
  • Thursday
09:00 AM PDT | 12:00 PM EDT

3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion

FDA steadily expands the scope and restrictions for the promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume you're talking to FDA.

Casper Uldriks Casper Uldriks | Duration: 3 Hours | Price: $299.00 | View Details
  • 22
  • March
  • 22
  • Friday
10:00 AM PDT | 01:00 PM EDT

Value Stream Mapping

This webinar will begin by defining value stream mapping and the key terms that comprise the VSM process. The purpose of VSM, important to participant focus, will also be discussed.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 22
  • March
  • 22
  • Friday
10:00 AM PDT | 01:00 PM EDT

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View Details
  • 22
  • March
  • 22
  • Friday
09:00 AM PDT | 12:00 PM EDT

Learn the Dos and Don'ts of Opening Business Bank Accounts

It's about time we leverage the tools and resources to make us more effective and efficient. I’m talking about ChatGPT. As with any tools, there are pros and cons. We will discuss the background, understanding general concepts, the tools available and what the future may bring.

Justin Muscolino Justin Muscolino | Duration: 60 Minutes | Price: $149.00 | View Details
  • 25
  • March
  • 25
  • Monday
10:00 AM PDT | 01:00 PM EDT

Project Management for Non-Project Managers - How to Effectively Monitor and Control Your Project

This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 25
  • March
  • 25
  • Monday
10:00 AM PDT | 01:00 PM EDT

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $149.00 | View Details
  • 25
  • March
  • 25
  • Monday
10:00 AM PDT | 01:00 PM EDT

Excel - Beyond Charts: Unleashing Creative Data Visualization

Revolutionize the way you communicate data with this cutting-edge training on Excel visual storytelling. Discover the power of visual data representation to transform complex numerical information into compelling, insightful visual narratives

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 26
  • March
  • 26
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on Inspection and Audit Readiness Training for Medical Device Manufacturers

There has been a major shift in the emphasis of U.S. FDA CGMP compliance audits over the past few years.

John E Lincoln John E Lincoln | Duration: 6 Hours | Price: $545.00 | View Details
  • 26
  • March
  • 26
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 26
  • March
  • 26
  • Tuesday
11:30 AM PDT | 02:30 PM EDT

Outlook Email Calendar & Contacts Essentials Masterclass

Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $149.00 | View Details
  • 27
  • March
  • 27
  • Wednesday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.

Casper Uldriks Casper Uldriks | Duration: 6 Hours | Price: $545.00 | View Details
  • 27
  • March
  • 27
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.

Dennis Taylor Dennis Taylor | Duration: 60 Minutes | Price: $149.00 | View Details
  • 27
  • March
  • 27
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 27
  • March
  • 27
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 28
  • March
  • 28
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Supervising a Human Error Free Environment: You can do a Lot More than you Think

Human error is known to be the major cause of quality and production losses in many industries.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 28
  • March
  • 28
  • Thursday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.

Charles H. Paul Charles H. Paul | Duration: 6 Hours | Price: $545.00 | View Details
  • 28
  • March
  • 28
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Risk based Computer System Validation

FDA requires that all software in computer systems used in GxP activities must be validated. The validation of computer system software is completely different from than validation of device software (embedded software). Validation is much more than testing. It is testing plus design control and configuration management.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 29
  • March
  • 29
  • Friday
10:00 AM PDT | 01:00 PM EDT

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 29
  • March
  • 29
  • Friday
10:00 AM PDT | 01:00 PM EDT

GAMP5, Second Edition and Alignment with Computer Software Assurance (CSA) and Digital Validation

We will explore the latest best industry practices offered in GAMP®5 (Second Edition) and understand what it offers to those validation computer systems in the FDA-regulated industries. We will cover the changes and impact on validation as a result. We will also cover FDA’s recent draft guidance on Computer Software Assurance (CSA) and what that means in terms of how to approach validation.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 29
  • March
  • 29
  • Friday
08:00 AM PDT | 11:00 AM EDT

Regulatory Compliance Quarterly: Discussing New Regulations From Each Of Our Regulators

In our current environment, Regulators have become more focused than ever to ensure financial institutions are operating with the consumer in mind.

Justin Muscolino Justin Muscolino | Duration: 60 Minutes | Price: $149.00 | View Details
  • 29
  • March
  • 29
  • Friday
11:30 AM PDT | 02:30 PM EDT

Excel Lookup Functions Xlookup & Error Suppression

Going “beyond the basics” Ray Evans clearly demonstrates, features and functionality that enhance the power and flexibility of lookup functions at intermediate level.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $149.00 | View Details
  • 29
  • March
  • 29
  • Friday
09:00 AM PDT | 12:00 PM EDT

3-Hour Virtual Seminar on IQ, OQ, and PQ in the Verification and Validation Process

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You'll learn about what processes need to be validated and what steps you need to take to validate processes.

Susanne Manz Susanne Manz | Duration: 3 Hours | Price: $299.00 | View Details
  • 1
  • April
  • 01
  • Monday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations

The Good Laboratory Practice regulations describe the minimal standards for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA or EPA such as animal food additives, human and animal drugs, medical devices for human use, biological products, electronic products, or pesticide products.

John E Lincoln John E Lincoln | Duration: 6 Hours | Price: $545.00 | View Details
  • 2
  • April
  • 02
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Controlling Human Error in the Manufacturing Floor

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 2
  • April
  • 02
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Medical Device Cybersecurity Following latest FDA Guidance

The company must establish a program where they identify, analyze and control cybersecurity risks for both pre-market and post-market. The cybersecurity program must be carefully planned. A formal special hazard analysis must be conducted for each risk. Communication of risks must be sent to devise users.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 2
  • April
  • 02
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Excel - Quick Tips to Help You be More Productive

Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 2
  • April
  • 02
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications.

David Nettleton David Nettleton | Duration: 90 Minutes | Price: $149.00 | View Details
  • 3
  • April
  • 03
  • Wednesday
11:30 AM PDT | 02:30 PM EDT

ChatGPT for Excel Essentials Made Easy

Gain easy-to-understand and practical "hands-on" knowledge of ChatGPT and Artificial Intelligence (AI) with a focus on significantly enhancing capabilities in Microsoft Excel.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $149.00 | View Details
  • 3
  • April
  • 03
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Validation of HPLC/UPLC Methodologies

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 4 & 5
  • April
  • 04
  • Thursday
08:00 AM PDT | 11:00 AM EDT

2-Day Virtual Seminar on Project Management for Non-Project Managers - PM in the Life Sciences - Pharmaceutical/ Biotechnology and Medical Devices

What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant. You are half listening to the presentation while thinking about some of the other work you need to complete on different matters. The installation will take a year to execute and will require the coordination with several functions inside and outside of the company.

Charles H. Paul Charles H. Paul | Duration: 2 Days | Price: $995.00 | View Details
  • 4
  • April
  • 04
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Leveraging the TPP top Get Better Advice from FDA

Most companies have no idea what a TPP (Target Product Profile) is and what it is not, or how and when to use it.

Arvilla Trag Arvilla Trag | Duration: 60 Minutes | Price: $149.00 | View Details
  • 4
  • April
  • 04
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Excel - 10 Key Worksheet Functions to Skyrocket Your Productivity

An often-asked question by Excel users is "Which Excel worksheet functions are truly essential?"

Mike Thomas Mike Thomas | Duration: 90 Minutes | Price: $149.00 | View Details
  • 5
  • April
  • 05
  • Friday
10:00 AM PDT | 01:00 PM EDT

Human Factors/ Usability Studies following ISO62366, the FDA Guidance and the new FDA Draft Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 5
  • April
  • 05
  • Friday
10:00 AM PDT | 01:00 PM EDT

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 5
  • April
  • 05
  • Friday
10:00 AM PDT | 01:00 PM EDT

The Most Common Problems in FDA Software Validation & Verification

This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View Details
  • 8
  • April
  • 08
  • Monday
10:00 AM PDT | 01:00 PM EDT

Project Management for Non-Project Managers - Scheduling your Project

This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 8
  • April
  • 08
  • Monday
10:00 AM PDT | 01:00 PM EDT

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 9
  • April
  • 09
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on FDA Audit Preparation, Inspection Conduct and Do's and Don'ts

This seminar is broken into two phases. Phase one corresponding to Day 1 will build basic knowledge of the inspection - the who, what, and when. Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.

Charles H. Paul Charles H. Paul | Duration: 6 Hours | Price: $545.00 | View Details
  • 9
  • April
  • 09
  • Tuesday
11:30 AM PDT | 02:30 PM EDT

ChatGPT for Excel Intermediate Masterclass

Harness the awesome power of AI to take Excel to a new level and boost your efficiency working smarter and faster.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $149.00 | View Details
  • 9
  • April
  • 09
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Excel - Master the Latest & Greatest 365-Only Functions

Elevate your Excel prowess with this training. Aimed at users already versed in Excel's core functions (SUM, X/VLOOKUP, COUNTIF etc), this course introduces users to some of the new innovative functions added since 2020, exclusively available to Microsoft 365 and Excel 2021 users

Mike Thomas Mike Thomas | Duration: 90 Minutes | Price: $149.00 | View Details
  • 10
  • April
  • 10
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

21 CFR Part 11 Conformance for Medical Devices

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 10
  • April
  • 10
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 10
  • April
  • 10
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Dealing with Difficult Customers Effectively

People and communications skills are very important in dealing with customers, but have little connection to doing good lab work. This webinar points out some approaches and skills to connect the two areas.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 11
  • April
  • 11
  • Thursday
08:00 AM PDT | 11:00 AM EDT

4-Hour Virtual Seminar on Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.

Robert J. Russell Robert J. Russell | Duration: 4 Hours | Price: $445.00 | View Details
  • 11
  • April
  • 11
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Balancing FDA Requirements with Investor Expectations

Executive management of many new virtual/small companies may have little to no prior biopharmaceutical industry experience; sometimes they do not have any pharma background at all.

Arvilla Trag Arvilla Trag | Duration: 60 Minutes | Price: $149.00 | View Details
  • 15
  • April
  • 15
  • Monday
10:00 AM PDT | 01:00 PM EDT

Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 15
  • April
  • 15
  • Monday
10:00 AM PDT | 01:00 PM EDT

Project Management for Non-Project Managers - Determining the Work that needs to be done

This webinar will walk the participant through the entire process of decomposing a project's tasks into workable schedulable elements called work packages.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 15
  • April
  • 15
  • Monday
10:00 AM PDT | 01:00 PM EDT

Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF)

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 15
  • April
  • 15
  • Monday
10:00 AM PDT | 01:00 PM EDT

FDA Good Meeting Practices Conducting Successful FDA Meetings

Virtually every medical device firm and pharmaceutical firm will need to meet with FDA as some time. To be prepared for these meetings and know how to handle them can be critical to the success of your business.

Larry Stevens Larry Stevens | Duration: 60 Minutes | Price: $149.00 | View Details
  • 16
  • April
  • 16
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Excel - Mastering Logic Functions

Become an Excel Hero in your organization! Make yourself indispensable. If these are your goals, having a good understanding of Excel's Logic functions is critical. It will help you with scenarios like these:

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 17
  • April
  • 17
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Project Management For Non-Project Managers - How To Communicate Project Actions And Progress - Conducting Effective Project Review Meetings

This webinar is about effective communication inside and outside of the project team. The webinar will use case studies and examples to reinforce key teaching points. Instruction will begin with a discussion of the communication model and the barriers that can erect obstacles to understanding the information and intent of the communications sent and received.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 17
  • April
  • 17
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

How to Deal with Bad Results Under GLP

Assessment of the cause for a non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 18
  • April
  • 18
  • Thursday
10:00 AM PDT | 01:00 PM EDT

How to Write SOP's for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 22
  • April
  • 22
  • Monday
10:00 AM PDT | 01:00 PM EDT

Medical Device Cybertechnology and FDA Compliance for Regulated Computer Systems and Data

This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 22
  • April
  • 22
  • Monday
10:00 AM PDT | 01:00 PM EDT

3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.

Robert J. Russell Robert J. Russell | Duration: 3 Hours | Price: $299.00 | View Details
  • 23
  • April
  • 23
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Preventing Human Error in the Life Sciences

This webinar will describe the nature of human error in terms of how it is manifest and it distinct properties. As human error is directly related to human performance, we must discuss the contribution human performance has upon the inherent error that is performed by workers in life science settings. The impact of human error in manufacturing will be examined as a prelude to the discussion of human error investigation and root cause determination.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 24
  • April
  • 24
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Engineering Change Control

This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 25
  • April
  • 25
  • Thursday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).

Robert J. Russell Robert J. Russell | Duration: 6 Hours | Price: $545.00 | View Details
  • 25
  • April
  • 25
  • Thursday
10:00 AM PDT | 01:00 PM EDT

How to Write SOP's that Avoid Human Error

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 26
  • April
  • 26
  • Friday
10:00 AM PDT | 01:00 PM EDT

Risk Based Design Control Requirements and Industry Best Practices for Medical Devices

This course will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. ISO 13485 has almost identical requirements. Such a program will also help to get projects completed on time and within budget.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 26
  • April
  • 26
  • Friday
10:00 AM PDT | 01:00 PM EDT

FDA Audit Best Practices - Do's and Don'ts

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 26
  • April
  • 26
  • Friday
10:00 AM PDT | 01:00 PM EDT

Computer System Validation (CSV) and Computer Software Assurance (CSA): Future Trends in Validation

Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 29
  • April
  • 29
  • Monday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).

John E Lincoln John E Lincoln | Duration: 6 Hours | Price: $545.00 | View Details
  • 30
  • April
  • 30
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Qualification of Contract Manufacturer Organizations Based on Practical Experience

"Regulatory agencies require that companies carefully select suppliers and contract manufacturers. The responsibility for product quality and safety remains with the company. It cannot be delegated to the CMO"

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 30
  • April
  • 30
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

The Human Error Toolbox: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 1
  • May
  • 01
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 2
  • May
  • 02
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Data Integrity And Human Error

Data integrity refers to the accuracy, completeness, and consistency of data over its entire lifecycle.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 2
  • May
  • 02
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity

This interactive webinar provides explicit details and a live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP-compliant spreadsheet application.

David Nettleton David Nettleton | Duration: 75 Minutes | Price: $149.00 | View Details
  • 8
  • May
  • 08
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Excel - Quick Tips to Help You be More Productive

Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 15
  • May
  • 15
  • Wednesday
08:00 AM PDT | 11:00 AM EDT

4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future

One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.

John E Lincoln John E Lincoln | Duration: 4 Hours | Price: $445.00 | View Details
  • 22
  • May
  • 22
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Excel - Reporting Simplified - Learn Pivot Tables from Scratch

Unlock the power of Excel's data analysis and Business Intelligence (BI) toolkit with Pivot Tables. Whether you're aiming to construct dynamic dashboards, conduct in-depth data analysis, or simply streamline data summaries for personal or business purposes, Pivot Tables are your key to success.

Mike Thomas Mike Thomas | Duration: 90 Minutes | Price: $149.00 | View Details
  • 4
  • June
  • 04
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Excel - Build Advanced Pivot Table Solutions Using the Data Model & PowerPivot

Your data is only as good as the information you can derive from it. Power Pivot enables you to gain better business insights and make more informed business decisions.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 4
  • June
  • 04
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification

This 2-Hour Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls.

David Nettleton David Nettleton | Duration: 2 Hours | Price: $199.00 | View Details
  • 10
  • June
  • 10
  • Monday
10:00 AM PDT | 01:00 PM EDT

Excel - Build Even More Powerful Pivot Tables: DAX Essentials

In today's data-driven world, having a strong command of Excel is essential, and understanding the Data Analysis Expressions (DAX) formula language is the key to unlocking the true potential of Excel's Power Pivot and Data Model features.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 18
  • June
  • 18
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Power BI Demystified: Transforming Data into Stunning Visuals

Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Demystified: Transforming Data into Stunning Visuals”

Mike Thomas Mike Thomas | Duration: 90 Minutes | Price: $149.00 | View Details
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