2014 - US, EU and Japan GMP Requirements- Practical ICH Area Differences and Healthcare Inspection Focus

Instructor: Angela Bazigos
Description:
This webinar reviews the latest developments in ICH Q7 GMP harmonization between US, EU and Japan. It describes how the advent of this guidance impacts the different countries and explains why the regulatory authorities of each country, still have divergent expectations, despite the harmonization. It then explains how to overcome the differences in the expectations of the US, EU and Japan regulatory authorities, to ensure successful inspections with minimum additional cost or effort.
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 webinarwill 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.
Objectives of the Presentation:
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 can Benefit:
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
Quick Contact
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