How to Prepare for a Regulatory Inspection: FDA, EMA, and Notified Body Audits

This 60-minute webinar provides a comprehensive guide on how to effectively prepare for regulatory inspections conducted by the FDA, EMA, and Notified Bodies.

It begins with an overview of the inspection processes and key focus areas for each regulatory authority, followed by practical strategies for pre-inspection preparation, including internal audits, staff training, and documentation readiness. Attendees will gain insights into best practices for managing inspections, from hosting auditors and handling document requests to responding to questions professionally. The session also covers post-inspection follow-up, including how to address findings, implement corrective actions, and ensure continuous compliance. With real-world insights and actionable strategies, this webinar equips life science professionals with the knowledge and confidence to navigate regulatory inspections successfully.

Why You Should Attend:
Participants should take this training to gain a clear, practical understanding of regulatory inspections conducted by the FDA, EMA, and Notified Bodies, ensuring they are fully prepared to navigate these critical audits with confidence. Regulatory inspections can significantly impact a company’s compliance status, market approvals, and reputation, making thorough preparation essential.

This training provides valuable insights into common compliance pitfalls, best practices for pre-inspection readiness, and effective strategies for managing auditors and responding to findings. By attending, participants will learn how to strengthen internal audit processes, enhance documentation practices, and develop a proactive approach to regulatory compliance, ultimately reducing the risk of non-compliance and improving their organization’s inspection outcomes.

Areas Covered in the Session:

• Introduction (5 minutes)
• Welcome and speaker introduction
• Overview of the importance of regulatory inspections
• Key regulatory agencies: FDA, EMA, and Notified Bodies - roles and expectations
• Understanding Regulatory Inspections (10 minutes)
• FDA Inspections
• Types (Routine, For-Cause, Pre-Approval, etc.)
• Key focus areas
• Inspection process and enforcement actions
• EMA Inspections
• GMP, GCP, and Pharmacovigilance inspections
• Risk-based approach to inspections
• Common observations
• Notified Body Audits (EU MDR/IVDR)
• Differences between regulatory inspections and NB audits
• Audit frequency and scope
• Trends in findings under EU MDR/IVDR
• Pre-Inspection Preparation (15 minutes)
• Internal audit and gap analysis
• Training staff for regulatory inspections
• Ensuring documentation readiness
• Quality Management System (QMS)
• Standard Operating Procedures (SOPs)
• Compliance records and data integrity
• Mock inspections and stress testing
• Managing the Inspection Process (15 minutes)
• Roles and responsibilities during an inspection
• Hosting inspectors and managing site tours
• Handling document requests and interviews
• Communication best practices:
• Do’s and Don’ts when interacting with inspectors/auditors
• Responding to questions effectively
• Post-Inspection Follow-Up (10 minutes)
• Reviewing inspection observations
• Preparing a Corrective and Preventive Action (CAPA) plan
• Responding to Form 483, Warning Letters, and non-conformities
• Continuous improvement and lessons learned

• Quality Assurance (QA)
• Regulatory Affairs
• Compliance Officers
• Manufacturing and Operations
• Clinical and Pharmacovigilance Teams
• Research and Development (R&D)
• Quality Control (QC)
• Supply Chain and Vendor Management
• Auditors and Internal Compliance Teams
• Senior Management and Executives in Life Sciences
• Documentation and Technical Writing Teams
• Training and Human Resources (HR) in Compliance-Related Roles
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