Change Control Mastery

Change control is one of the most essential and frequently scrutinized elements of a quality management system in the life sciences industry.

Whether an organization manufactures pharmaceuticals, biologics, cell and gene therapies, medical devices, diagnostics, or combination products, regulators expect every change that could impact product quality, safety, identity, purity, strength, performance, labeling, or regulatory filing accuracy to be systematically evaluated, justified, approved, implemented, and documented. A weak change control program can lead to compliance failures, costly product holds, supply interruptions, audit citations, and even enforcement actions such as warning letters or recalls. In contrast, a well-designed and consistently executed change control program strengthens operational control, reduces business risk, ensures traceability, and supports continuous improvement.

The webinar begins by grounding participants in the regulatory basis for change control, making it clear that the requirements are not optional business rules-they are legally enforceable expectations. U.S. FDA regulations (21 CFR Parts 210, 211, and 820), the emerging QMSR which aligns medical device requirements with ISO 13485, and global expectations found in EU MDR/IVDR and EMA guidance all emphasize that controlled change is fundamental to maintaining a validated state and regulatory compliance. ICH Q7, Q9, and Q10 further reinforce change control principles by linking them to risk management and the pharmaceutical quality system. Understanding these foundations is critical because inspectors consistently expect companies to demonstrate not only that they have a change control procedure, but also that they follow it consistently and can justify the impact of each change.

The session explains what qualifies as a change and why organizations often underestimate how broad the scope truly is. Changes can involve raw materials, components, suppliers, test methods, labeling, formulation, manufacturing processes, equipment, software, facilities, utilities, or controlled documents. Silent or creeping changes-changes made informally without proper documentation-are a major area of regulatory concern. Participants learn to recognize change triggers, such as deviations, CAPAs, audit findings, supplier communication, design improvements, or regulatory updates, and to ensure each trigger feeds into a formal evaluation process rather than being handled informally.

The webinar then provides a detailed overview of the change control workflow from initiation to closure. Strong change control requires comprehensive impact assessment, cross-functional collaboration, well-defined approval authority, implementation planning, validation decisions, and effective communication. Participants learn how risk-based decision-making and justification are critical to determining whether re-validation, additional testing, or updated regulatory submissions are required. The ability to document rationale thoroughly is emphasized as one of the most powerful tools for defending decisions during inspections.
Finally, the session concludes with the most common mistakes that lead to inspection findings and the best practices used by high-performing companies. Frequent pitfalls include incomplete assessments, lack of traceability to validation, inadequate justification, and poor documentation of scientific reasoning. Best practices include standardized templates, decision trees, training programs, governance oversight, and ongoing effectiveness checks after implementation. Attendees leave with a clear understanding of how to build and maintain a robust change control system that protects patients, supports compliance, and enables continuous improvement without operational disruption.

Why you should Attend:
In today's highly regulated life sciences industry, change control has become one of the most visible indicators of whether a company truly understands and manages compliance risk. Regulators consistently focus on how organizations evaluate, justify, and document changes, making change control a prime source of citations, warning letters, and costly operational delays. Participating in this training gives professionals the practical knowledge needed to avoid these pitfalls and strengthen their organization's quality system.

Attendees will learn how to recognize the full scope of activities that require change control-far beyond document updates or engineering modifications-and understand the regulatory and scientific rationale behind each step of a compliant process. The session provides tools to perform robust impact assessments, integrate quality risk management, and determine appropriate validation requirements. Participants will gain insight into how to write defensible justifications that withstand inspection scrutiny and how to design change control workflows that promote cross-functional ownership rather than bureaucratic delay.

Whether someone works in manufacturing, engineering, validation, QA/RA, supply chain, R&D, or executive leadership, mastering change control improves decision-making and reduces business risk. This training equips attendees with practical strategies and templates they can apply immediately to support compliance, protect product quality, and maintain an uninterrupted state of control.

Areas Covered in the Session:

• Welcome & Introduction (5 minutes)
• Purpose of change control in regulated environments
• Why uncontrolled change leads to compliance risk
• Goals of the webinar: control risk, ensure traceability, maintain validation
• Regulatory Foundations for Change Control (10 minutes)
  • FDA expectations (21 CFR Parts 210, 211, 820; QMSR link to ISO 13485)
  • EU MDR/IVDR and EMA focus on design/manufacturing controls
  • ICH Q7/Q9/Q10 principles (quality system + risk management + continuous improvement)
  • Auditor hot topics: documentation gaps, traceability failures, risk justification
• What Defines a Change? (10 minutes)
• Types: process, product, specification, equipment, utilities, suppliers, software, documents
• Planned vs. unplanned changes
• Silent/creeping changes and undocumented adjustments
• Triggers: CAPA, deviations, audit findings, supplier updates, regulatory changes
• Change Control Process Essentials (15 minutes)
• Change request initiation and required data
• Impact assessment: cross-functional review and risk evaluation
• Approval workflow and defined authority levels
• Implementation planning and communication requirements
• Validation, qualification, and re-verification needs
• Final effectiveness/close-out with objective evidence
• Quality Risk Management Integration (10 minutes)
• Using risk tools (FMEA, hazard assessment, cause-effect analysis)
• Risk ranking and priority selection
• Linking risk to testing, validation, sampling, and justification for no re-validation
• Documentation of rationale vs. evidence
• Common Pitfalls & Best Practices (5 minutes)
• Incomplete impact assessment
• Poor documentation of rationale
• Lack of cross-functional ownership
• Effective controls: templates, training, periodic review, metrics, governance
• Q&A and Closing (5 minutes)
• Key takeaways and final questions
• Additional resources and advanced learning options

• Quality Assurance
• Quality Control
• Regulatory Affairs
• Manufacturing
• Operations
• Engineering
• Validation / Qualification
• Research & Development
• Supply Chain
• Procurement
• Technical Services
• Document Control
• Materials Management
• Information Technology (IT / CSV)
• Project Management
• Executive Leadership / Quality Governance