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What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
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.
Overview of the webinar
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.
Who should attend?
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
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 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.
Faculty - Mz.Angela Bazigos
Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA.
Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry.
Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.