3-Hour Virtual Seminar on What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
This Webinar will provide valuable assistance to all License Owner personnel in the Pharmaceutical, Biotechnology, Medical Device and Combination Products areas, including contract manufacturers, packagers and suppliers.
Thursday, March 25, 2021
09:00 AM PST | 12:00 PM EST
3 Hours
More Trainings by this Expert Product Id : 503524
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.
Areas Covered in the Session:
US, EU, Japan GMP Requirements (Practical ICH Area Differences, Healthcare Authority Inspection Focus)
- U.S., EU and Japan GMPs - Status of Harmonization & FutureTrends
- Current status of harmonization of GMP requirements
- Future Trends
- Discrepancies in global expectations
- Alignment issues
- ICH GMP organization
- Category reviews
- 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
- Auditing API facilities
- Typical audit agenda
- ICH Area differences
- Auditing finished product facilities
- Typical audit agenda
- ICH Area differences
- Differences on how GMP inspections are conducted
- Areas of GMP inspection focus by area
- Modifying your self-inspection systems to customized area concerns
- Contract manufacturing
- Contract packaging
- 3rd Party Contract testing
- Importance of pre-audits to regional GMP focus
- How to focus your internal audits to a US, EU and Japan compliance system
Who Will Benefit: This Webinar will provide valuable assistance to all License Owner personnel in the Pharmaceutical, Biotechnology, Medical Device and Combination Products areas, including contract manufacturers, packagers and suppliers. Particular functional expertise, for both full time and consulting personnel that would receive value from attending includes:
- 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
Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance https://www.google.com/patents/US8266578.
Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.
Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences.