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

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Webinar Duration: 90 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Angela Bazigos

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: This Webinar will provide valuable assistance to 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

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/4FA562336EBD46C58CDC43A8B7773095.ashxPatent 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/using-training-to-bring-compliance-to-boardrooms/ 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.7144112.html#overview.

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