Online Webinar 2019 - 3 Hrs Live Webinar What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections

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
a) Current status of harmonization of GMP requirements
b) Future Trends
2) Where Inconsistencies Become a Problem: WHO, ICH, Countries
a) Discrepancies in global expectations
b) Alignment issues
3) Key Chapter Reviews
a) ICH GMP organization
b) Category reviews
4) Compliance with ICH Guidelines for GMPs
a) Understanding and Insight into Healthcare Authority expectations
b) How GMP requirements/inspections can differ with a single ICH Standard
c) How regulators (from 3 regions) will assess / enforce compliance with Q7
5) APIs
a) Auditing API facilities
b) Typical audit agenda
c) ICH Area differences
6) Finished Products
a) Auditing finished product facilities
b) Typical audit agenda
c) ICH Area differences
7) Excipients
8) Sterile products
9) Biologics
10) Clinical Packaging
11) Area GMP Inspections
a) Differences on how GMP inspections are conducted
b) Areas of GMP inspection focus by area
c) Modifying your self-inspection systems to customized area concerns
12) Outsourcing Management Regional Perspective on:
a) Contract manufacturing
b) Contract packaging.
c) 3rd Party Contract testing
13) Auditing Your Facilities for Global Considerations
a) Importance of pre-audits to regional GMP focus.
b) 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 Profile
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; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.