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

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 180 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 180 mins Live Webinar

"Hear By Angela Bazigos who recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom"

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients


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 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.

Areas Covered

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
•          Where Inconsistencies Become a Problem: WHO, ICH, Countries
               •        Discrepancies in global expectations
               •        Alignment issues
•          Key Chapter Reviews
               •        ICH GMP organization
               •        Category reviews
•          Compliance with ICH Guidelines for GMPs
               •        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
•          APIs
               •        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
•          Area GMP Inspections
               •        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:
               •        Contract manufacturing
               •        Contract packaging.
3rd Party Contract testing
•          Auditing Your Facilities for Global Considerations
               •        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

•          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

Industries who can attend

This 180-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

Angela Bazigos

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer 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 Life Sciences.

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