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

DESCRIPTION
This 90 minute webinar will help you gain a detailed overview of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will help prepare you for regulatory inspections in these countries.
Why Should You Attend?
This ICH GMP training course will provide your company the opportunity for a detailed overview of ICH GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan).It will cover the key areas of how ICH 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.
Areas Covered in the Seminar :
US, EU, Japan GMP Requirements(Practical ICH Area Differences, Healthcare Authority Inspection Focus)
I . U.S., EU and Japan GMPs - Status of Harmonization and Where We're Heading
Current efforts to further harmonize GMP requirements
Future expectation & likely progress
II . Where Inconsistencies Become a Problem: WHO, ICH, Countries
Flexibility in global expectations
Most challenging topics where alignment varies
III . Key Chapter Reviews
ICH GMP organization
Category reviews
IV . 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
V . GMP Comparisons for APIs
Auditing API facilities
Typical audit agenda
ICH Area differences
VI . GMP Comparisons for Finished Products
Auditing finished product facilities
Typical audit agenda
ICH Area differences
VII . GMP Comparisons for :
Excipients
Sterile products
Biologics
Clinical Packaging
VIII . Differences on 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
IX . Outsourcing Management. A Regional Perspective on:
Contract manufacturing
Contract packaging.
3 rd Party Contract testing
X . 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:
This Webinar will provide valuable assistance to all License Owner personnel in the Pharmaceutical, Biotechnology and Combination Products areas, including contract manufacturers, packagers and suppliers. Particular functional expertise receiving value from attending would be:
Manufacturing
Quality Assurance
Senior management
Project Managers
Qualified Persons (QPs)
Regulatory Compliance
CMC Personnel
Packaging Experts
Auditors and Staff
Consultants
Webinar Includes:
Q/A Session with the Expert to ask your question
Handouts (PDF print only copy of PowerPoint slides)
90 Minutes Live Presentation
Certificate of Attendance