3-Hour Virtual Seminar on cGMP Regulatory Inspections – Through the Eyes of FDA, EMA and PMDA

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 You Should Attend:

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.

Seminar Agenda:

Session 1:

• U.S., EU and Japan GMPs – Status of Harmonization& Future Trends
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  • Current status of harmonization of GMP requirements
  • Future Trends
• Where Inconsistencies Become a Problem: WHO, ICH, Countries
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  • Discrepancies in global expectations
  • Alignment issues
• Key Chapter Reviews
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  • ICH GMP organization
  • Category reviews
• Compliance with ICH Guidelines for GMPs
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  • Understanding and Insight into Healthcare Authority expectations
  • How GMP requirements/inspections can differ with a single ICH Standard
  • How regulators (from 3 regions) will assess / enforce compliance with Q7

Session 2:

• APIs
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  • Auditing API facilities
  • Typical audit agenda
  • ICH Area differences
• Finished Products
• 
  
  • Auditing finished product facilities
  • Typical audit agenda
  • ICH Area differences
• Excipients
• Sterile products
• Biologics
• Clinical Packaging

Session 3:

• Area GMP Inspections
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  • Differences on how GMP inspections are conducted
  • Areas of GMP inspection focus by area
  • Modifying your self-inspection systems to customized area concerns
• Outsourcing Management Regional Perspective on:
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  • Contract manufacturing
  • Contract packaging.
  • 3rd Party Contract testing
• Auditing Your Facilities for Global Considerations
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  • Importance of pre-audits to regional GMP focus.
  • How to focus your internal audits to a US, EU and Japan compliance system.

Who Should Attend:

• Manufacturing Departments
• Regulatory Affairs Departments
• Quality Assurance Departments
• Quality Control Departments
• Research and Development Departments
• Project Managers
• CMC Personnel
• Packaging Experts
• Auditors and Staff
• IT Subject Matter Experts