FDA Compliance 2018 - What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections

Overview:
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.
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. .
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
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
Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. 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, http://morflearning.com/angelabazigos/, 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 http://www1.diahome.org/~/media/4FA562336EBD46C58C... on speeding up software compliancehttps://www.google.com/patents/US8266578 . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroomhttp://blogs.wsj.com/riskandcompliance/2015/07/24/... 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: http://www.stanfordwhoswho.com/Angela.Bazigos.7144....
Event link : http://www.compliance4all.com/control/w_product/~p...
Contact Details:
NetZealous LLC, DBA compliance4All
Phone: +1-800-447-9407
Email: support-AT-compliance4All.com