FDA Best Audit Practices – Get Ready For The Inspection That Is Coming

1. Live Webinar on FDA Inspection Readiness – Preparing for an Inspection Name of the Presenter. Charles H Paul, President C. H. Paul Consulting, Inc.

2. Topics The mechanics of the readiness process, auditing – who gets audited, frequency of audits, and the inspection process explained Types of inspections and their implications The heart of compliance – doing the right things right Selecting your subject matter experts Training your SME’s – what do they need to know and how do you train Inspection preparedness – what to expect and how to prepare The readiness inspection from the auditor’s perspective Responding/interacting with the inspection team – inspection behavior – how to act – what to say and what not to say ◼ ◼ ◼ ◼ ◼ ◼ ◼ ◼ 2

3. Who does the FDAInspect? Federal Food, Drug, and Cosmetics (FD&C) Act, domestic drug establishments, and Class II and Class III device manufacturers inspected every two years ◼ Foreign manufacturers ◼ Inspections conducted based on risk ◼ Higher-risk products more likely to be audited ◼ Facilities having historically significant violations ◼ Inspection focus  Quality and Product Safety  Facility  Process  Data ◼ 3

4. Purpose of Inspections • Compliance with FDAregulations • Product development • Quality System (QS) and manufacturing practices • Controls are in-place and they are effective • Recalls, enforcement actions, complaints, significant adverse event reports, surveillance • Ensure consumer protection 4

5. Types of Inspections ◼ Pre-Approval Inspections (PAI Post-Approval Inspections ◼ Surveillance Inspections ◼ For-Cause or Triggered Inspections ◼ Compliance Follow-Up Inspections ◼ Foreign Inspections ◼ Focused Inspections ◼ Risk-Based Inspections ◼ Follow-Up or Recurrent Inspections ◼ Adverse Event Inspections ◼ Import Inspections ◼ Bioequivalence and Bioavailability Inspections 5

6. Types of Inspections ◼ Pre-Approval Inspections ◼ Post Approval Audit Inspections ◼ Drug Manufacturing Inspections 6

7. Pre-Approval Inspections ◼ FDA approves New Drug Applications, Abbreviated New Drug Applications, Biologic Licensing Applications ◼ Assure that controls for manufacture, processing, packing, and testing are adequate ◼ Pre-approval inspection performed to ensure that manufacturer can manufacture the drug. 7

8. Post Approval Audit Inspections ◼ Designed to audit for changes in the production and control practices that occur after approval ◼ Post Approval Audit Inspections confirm that commitments have been completed or are underway 8

9. Drug Manufacturing Inspections To determine whether inspected firms are operating in compliance with applicable cGMP requirements 9

10. Best Practices – “Do the right Things Right” ◼ Preparation • Have adequately trained staff with relevant expertise and accountability. • Obtain upper management support • Utilize and value independent regulatory compliance and quality assurance teams • Ensure the commitments made from previous inspections have been implemented • Understand your potential quality data sources so information can be quickly and easily sourced as required • Implement and assess an effective quality system • Ensure there is a designated company Inspection Team • Ensure all proper documentation and records are up-to-date • Maintain effective Management Review and CAPAsystems. • Identify true root causes of issues using appropriate problem-solving tools. • Understand when a product, or quality issue is significant. • Have defined metric systems to monitor your quality system in order to identify trends, gaps, and opportunities 10

11. Inspection Process Overview ❑ Alert system activated ❑ Company Inspection Team members assemble ❑ FDAprovides the company with Form 482 ❑ FDAwill explain why they are at your site ❑ FDAprovided with a facility tour ❑ FDAinspection team, will request the documents they need ❑ FDA will conduct the Exit Inspection Meeting. ❑ FDA findings are reviewed 11

12. Post Inspection • Date of inspection • Inspection team members • Reasons for response • Response to each cited deficiency • Description of preventive and corrective action • Items still in dispute 12

13. Post Inspection ◼ If the inspection has an Official Action Indicated classification, FDA send a warning letter ◼ Company will need to reply ◼ FDAconducts a follow-up inspection ◼ FDAmay issue a close-out letter 13

14. Why are SME’s Indispensable to the Organization? ◼ Expertise in Specific Areas ◼ Demonstrating Compliance ◼ Preparing Documentation ◼ Training and Coaching Staff ◼ Addressing Non-Compliance Issues ◼ Facilitating Communication ◼ Ensuring Ongoing Compliance 14

15. Who are SMEs? ◼ Quality Assurance (QA) and Quality Control (QC) Experts ◼ Regulatory Affairs Specialists ◼ Manufacturing and Process Engineers ◼ Microbiologists and Chemists ◼ Clinical Research Professionals ◼ Pharmacovigilance Experts ◼ Labeling and Packaging Specialists ◼ Validation Experts ◼ Food Safety and HACCP Experts ◼ Clinical Laboratory Directors ◼ Environmental Health and Safety Specialists ◼ Documentation and Records Management Experts 15

16. Why is Proper SME Selection Important to the FDA Inspection? ◼ Accuracy and Credibility ◼ Regulatory Understanding ◼ Effective Communication ◼ Smooth Inspection Process ◼ Confidence and Professionalism ◼ Problem-Solving Abilities ◼ Representation of Expertise ◼ Mitigating Risks ◼ Resource Efficiency ◼ Long-Term Impact ◼ Employee Morale ◼ Organizational Preparedness 44

17. Selecting SMEs ◼ Identify Relevant Areas ◼ Define SME Criteria ◼ Cross-Functional Representation ◼ Regulatory Knowledge ◼ Communication Skills ◼ Experience with Inspections ◼ Problem-Solving Abilities ◼ Preparation and Training ◼ Calm Under Pressure ◼ Collaborative Attitude ◼ Post-Inspection Feedback 17

18. Preparing SME’s ◼ Provide In-Depth Regulatory Training ◼ Review Inspection Process and Expectations ◼ Mock Inspection Workshops ◼ Communication Skills Training ◼ Prepare Documentation ◼ Familiarize with Facility Layout ◼ Prepare for Questions ◼ Confidence Building ◼ Team Collaboration ◼ Role-Playing Scenarios ◼ Post-Preparation Feedback 18

19. Doing the Right Thing ◼ Always be professional ◼ Be dressed properly – neat and clean ◼ Follow all company cleanliness, movement, and dressing requirements ◼ Be courteous and polite at all times ◼ Correct all errors and miscommunications when discovered as soon as possible 19

20. What a Successful FDA Audit Looks Like ◼ Compliance with Regulations ◼ Public Health and Safety ◼ Market Confidence ◼ Continued Market Access ◼ Operational Improvements ◼ Reduced Legal and Financial Risk ◼ Enhanced Consumer Trust ◼ Facilitates Innovations ◼ Employee Morale and Engagement ◼ Educational Opportunity 20

21. Tips for Doing it Right ◼ Understand the Scope and Standards ◼ Maintain Compliance at All Times ◼ Conduct Regular Internal Audits ◼ Prepare Your Team ◼ Organize Documentation ◼ Review Past Inspections ◼ Mock Inspections ◼ Improve Communication Skills ◼ Ensure Facility Readiness ◼ Stay Informed About Industry Changes ◼ Legal and Expert Consultation ◼ Handle Issues Professionally 21

22. Review ◼ Always be prepared by doing the right things right ◼ Always maintain a compliant GMP environment ◼ Have effective and accessible compliance documentation ◼ Have a plan for how you will manage your inspection ◼ Be professional during an inspection ◼ Demonstrate proper body language ◼ Be timely in providing the documents and samples requested ◼ Control the flow of communication ◼ Properly answer questions ◼ Respond to findings thoroughly and in a timely manner 22

23. Questions Register Now 69