Boston Professional Events List


What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections


Date
Feb 05, 2019 - 10:00 AM - 01:00 PM
Organizer
WCS
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,

Hollywood,
Florida,
US,
ZIP: 33021
Phone: 844-267-7299 | 954-947-5671

Overview

GMP-compliance is a must for manufacturers of finished pharmaceutical products and active pharmaceutical ingredients (APIs) according to the different national legislations. The related GMP rules are typically valid for one country based upon the anchoring in the respective national laws. However, at the same time the GMP rules are more or less internationally harmonized such as e.g. the ICH Q7 Guidelines representing the “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” being adopted by the regulatory bodies of the European Union (EU), Japan and USA.


Why should you
It has often been stated that “FDA inspects for compliance; European inspectors inspect for adequate science”. Yet GMPs have been enshrined into law for many countries and a drug/biologic/medical device manufacturer should have a reasonable expectation of all inspections being the same.
ICH Q7 was established by US / EU and Japan to harmonize inspections in their respective countries. This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.. After this event, you will be fully prepared for cGMP regulatory inspections in those countries.


Session Highlights
US, EU, Japan GMP Requirements (Practical ICH Area Differences, Healthcare Authority Inspection Focus)
  1. U.S., EU and Japan GMPs - Status of Harmonization& FutureTrends
  2. Current status of harmonization of GMP requirements
  3. Future Trends
  4. Where Inconsistencies Become a Problem: WHO, ICH, Countries
  5. Discrepancies in global expectations
  6. Alignment issues
  7. Key Chapter Reviews
  8. ICH GMP organization
  9. Category reviews
  10. Compliance with ICH Guidelines for GMPs
  11. Understanding and Insight into Healthcare Authority expectations
  12. How GMP requirements/inspections can differ with a single ICH Standard
  13. How regulators (from 3 regions) will assess / enforce compliance with Q7
  14. APIs
  15. Auditing API facilities
  16. Typical audit agenda
  17. ICH Area differences
  18. Finished Products
  19. Auditing finished product facilities
  20. Typical audit agenda
  21. ICH Area differences
  22. Excipients
  23. Sterile products
  24. Biologics
  25. Clinical Packaging
  26. Area GMP Inspections
  27. Differences on how GMP inspections are conducted
  28. Areas of GMP inspection focus by area
  29. Modifying your self-inspection systems to customized area concerns
  30. Outsourcing Management Regional Perspective on:
  31. Contract manufacturing
  32. Contract packaging.
  33. 3rd Party Contract testing
  34. Auditing Your Facilities for Global Considerations
  35. Importance of pre-audits to regional GMP focus.
  36. How to focus your internal audits to a US, EU and Japan compliance system.



Who Will Benefit

 

  • Manufacturing
  • Quality Control
  • Quality Assurance
  • Senior Management
  • Project Managers
  • Qualified Persons (QPs)
  • Regulatory Compliance
  • CMC Personnel
  • Packaging Experts
  • Auditors and Staff
  • IT Subject Matter Experts


Speaker Details


Ms. Kelly Thomas

Ms. Kelly Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems;

Event Categories
Keywords: pharmaceutical




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