This session will provide insights on moving from the traditional regulatory strategies for mature technologies to the new regulatory strategies for novel uses of AI and ML while engaging FDA and/or Notified Bodies in the effort. The IMDRF, US and EU perspectives on what's next for AI and ML as SaMD will be explored.
In today's world, there are tons of data to manage. Data is coming from many different sources.
Still unsure? Consider this: regulators are already discussing AI's implications for financial services.
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
This webinar will discuss the Q-Submission program, with includes Pre-Subs, Submission Issue Requests (SIRS), Study Risk Determinations, Informational Meetings, PMA 100-Day Meetings, and other meetings and uses for Q-Sub requests.
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Verification and validation of design inputs is a critical step in the development of medical devices.
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product.
This session is designed to eliminate that uncertainty. You'll learn how to read income statements, balance sheets, and cash flow statements with confidence. More importantly, you'll gain the skills to analyze what the numbers actually mean: profitability trends, liquidity issues, debt levels, and more. By the end of this training, you'll be able to speak the language of finance-and use it to your advantage.
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
This training is designed to revolutionize the way you work with Excel. Copilot is an AI-powered tool that enhances your Excel experience by automating complex tasks, providing intelligent suggestions, and improving overall efficiency. Whether you're dealing with large datasets, creating intricate formulas, or simply trying to streamline your daily workflow, Copilot is here to help.
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities by applying a sound, project management approach. Each validation effort includes a vast set of activities and tasks required to get the job done. These can be managed more effectively by better understanding how to apply a project management approach to them all, regardless of size.
ISO 9001 is an internatioinal standard for Quality Management Systems for all business or industrial systems, and is used as such by companies worldwide.
This training is your opportunity to eliminate that uncertainty.
In this webinar, we will discuss how to successfully prepare for and host a regulatory audit at you site. We will delve into how to prepare for the arrival of the auditors, what kind of people with what skills are needed for the audit team and how to conduct the audit.
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products.
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.
This session will equip you with the knowledge and tools needed to identify risks, strengthen internal processes, and implement practical safeguards.
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.
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques with ChatGPT / AI assistance for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
FDA's recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries.
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.
Assessment of the cause for a non-compliance is a structured series of branching questions.
The fear is real-many professionals nod in meetings where financials are discussed, but don't fully understand what the ratios mean or how they relate to strategic decisions.
A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety and efficacy of the manufactured drug.
In particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
An often-asked question by Excel users is "Which Excel worksheet functions are truly essential?"
If you work in the GMP-regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must do it because the regulation requires it.
This training helps you bridge the gap between financial analysis and impactful communication.
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel.
This session is designed to help you recognize these risks and take action.
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k).
In today's busy world, we are sometimes overwhelmed with huge amounts of data, sometimes that data can come from more than one table, or even more than 1 data source. Trying to make sense of this data can be an overwhelming task.
Advancements in technology have forced organizations to rethink business models.
Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Getting Started Building Reports and Dashboards"
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Embark on a transformative journey to enhance your decision-making skills and fortify your ability to prevent human errors with our comprehensive course on "Decision-Making and Human Error Prevention."
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
This 60-minute webinar provides a comprehensive guide on how to effectively prepare for regulatory inspections conducted by the FDA, EMA, and Notified Bodies.
We will explore the best practices and strategic approach for evaluating Excel spreadsheets used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.
It is important that the sterile filtration process is fully understood and properly validated for your particular application.
Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.
Data protection and privacy is an important issue this day and age for the public. People want to make sure they are protected. With the rules & regulations for organizations becoming stricter as we move forward, this will help confidence with the public.
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.
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.
Human error is the primary cause of quality and production losses in many industries.
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.
This easy to follow demonstration clearly explains how to effectively post ChatGPT questions on more advanced Excel topics and extract more accurate responses.
This webinar will examine the existing requiements for theUS FDA's DHF - including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF.
A customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
Trade deals and tariff negotiations are key tools governments use to influence economic outcomes, build alliances, and protect domestic industries.
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences.
An often-asked question by Excel users is "Which Excel worksheet functions are truly essential?"
The first four C's-capacity, conditions, collateral, and character- evaluate a borrower's ability to repay, but character forces the lender to examine closely the borrower's willingness to repay.
Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.
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.
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products.
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.
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
This Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means increased exposure.
Going "beyond the basics" Ray Evans clearly demonstrates, features and functionality that enhance the power and flexibility of lookup functions at intermediate level.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
This course is designed to teach learners how to use Gemini AI with Google Sheets, a powerful tool that can help you automate tasks, analyze data, and create reports in Google Sheets.
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.
Mastering Power-User techniques in Microsoft Word is vital in a wide range of professions and fields including public service, banking, accounting, financial analysis, and business administration.
Human error is known to be the primary cause of quality and production losses in many industries. Although human error is unlikely to ever be eliminated, many human performance problems can be prevented.
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Getting Started Building Reports and Dashboards"
There is an old saying in credit analysis, "Borrowers pay back loans from cash flow, not profits."
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.
Effective collaboration between diverse corporate functions is critical for success in Research & Development (R&D).
This course is designed to teach learners how to use COPILOT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of COPILOT for Excel, like basic navigation and data analysis.
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.
This course is not appropriate for Mac or Excel for Web users as the functionality does not exist on those platforms.
A customized practical PowerPoint example is provided with slides in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
The artificial intelligence technologies granted FDA marketing authorization and cleared by the agency so far are generally called “locked” algorithms that don’t continually adapt or learn every time the algorithm is used.
As global trade undergoes profound changes, companies and governments must look beyond today's tariff challenges and prepare for a more complex, uncertain future.
Credit Risk Management is the function that ensures the organization is balancing its risk appetite with its risk tolerance to attain the organization's desired credit risk objectives.
Effective risk management is essential for ensuring the success of life science projects, where regulatory compliance, operational efficiency, and financial sustainability are critical.
We will discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately, in accordance with FDA's guidance.
Every day we deal with issues and hope to resolve them correctly, quickly, and cheaply.
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.
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.
A customised practical Excel Worksheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
Finance & Accounting 101 Simplified strips away the jargon and explains key financial and accounting concepts in everyday terms.
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel.
Credit Risk Management is the function that ensures the organization is balancing its risk appetite with its risk tolerance to attain the organization’s desired credit risk objectives.
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.
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.
In today's fast-paced and data-driven world, efficiency, accuracy, and innovation are more critical than ever. This session will introduce you to the seamless integration of ChatGPT with Excel, showing how AI can dramatically boost your spreadsheet capabilities.
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.
A customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Both lenders and borrowers like to to use EBITDA as proof of repayment ability, but as noted earlier, it overestimates repayment ability.
Medical device submissions in the US and EU require precise project scheduling to ensure timely regulatory approvals.
Still unsure? Consider this: regulators are already discussing AI's implications for financial services.
Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.
This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts.
Ratio analysis helps lenders and analysts to determine a borrower's operating performance (profitability and productivity) and financial condition (liquidity, leverage, solvency) by rendering the financial statements into ratios.
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.
Advancements in technology have forced organizations to rethink business models.
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Going "beyond the basics" Ray Evans clearly demonstrates, features and functionality that enhance the power and flexibility of lookup functions at intermediate level.
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
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.
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products.
Advancements in technology have forced organizations to rethink business models.
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.
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Human Factors/ Usability is the analysis of how people interact with medical devices.
The US FDA has announced steps toward a new regulatory policy and framework specifically tailored to promote the development of safe and effective drugs using advanced artificial intelligence / machine learning algorithms by the regulated industry.
Good leaders walk the talk, but they also write right. They know how to say in a few words what needs to be said in crisp, clear language.
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k).
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.
This webinar, Decoding FDA's 21 CFR Part 11 and EU Annex 11: Ensuring Compliance in Electronic Recordkeeping, provides a comprehensive understanding of regulatory requirements for electronic records and electronic signatures in the pharmaceutical, biotechnology, and medical device industries.
We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.
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.
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
This 60-minute webinar explores how ChatGPT can revolutionize technical writing by enhancing productivity, accuracy, and clarity in document creation.
An often-asked question by Excel users is "Which Excel worksheet functions are truly essential?"
So what is next for the modernization of the processes involved in compliance for FDA-regulated systems, keeping in mind the guidance documents provide thus far?
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.
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences.
Credit Risk Management is the function that ensures the organization is balancing its risk appetite with its risk tolerance to attain the organization’s desired credit risk objectives.
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.
Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Getting Started Building Reports and Dashboards"
As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI is becoming prevalent.
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
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, Excel 2021 and Excel 2024 users.
This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications.
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizen's personal data when they reside in the European Union (EU).
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.
This training is designed to revolutionize the way you work with Excel. Copilot is an AI-powered tool that enhances your Excel experience by automating complex tasks, providing intelligent suggestions, and improving overall efficiency. Whether you're dealing with large datasets, creating intricate formulas, or simply trying to streamline your daily workflow, Copilot is here to help.
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products.
Good leaders walk the talk, but they also write right. They know how to say in a few words what needs to be said in crisp, clear language.
FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules.
FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA's current thinking on computer systems that are validated and subject to inspection and audit.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
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.
Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.
Assessment of the cause for a non-compliance is a structured series of branching questions.
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
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.
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
A compliant training program is essential for ensuring personnel in GMP, GCP, and quality system-regulated environments are knowledgeable, competent, and audit-ready.
Effective Standard Operating Procedure (SOP) writing and management are critical for ensuring regulatory compliance and operational consistency.
This webinar will provide a practical framework for identifying, analyzing, and addressing deviations in pharmaceutical and biopharmaceutical manufacturing.
This webinar, Data Integrity in GMP and GCP: Compliance with FDA, EMA, and MHRA Requirements, provides a comprehensive overview of data integrity principles, regulatory expectations, and compliance strategies in pharmaceutical and clinical environments.
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