cGMP Training Overview
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 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.
Webinar Takeaway
Session 1:
U.S., EU and Japan GMPs - Status of Harmonization& Future Trends
- 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
Session 2:
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
Session 3:
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
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IT Subject Matter Experts
Kelly Thomas (25+ year exp.)
Vice President, Americas Quality Operations at Stallergenes Greer - Charlotte Metro USA
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Over 20 years’ experience leading facility start-ups, PAI and Routine cGMP Surveillance inspections. Highly successful global regulatory and ISO compliance history with inspections including FDA, EMEA, IMB, JP, Health Canada, and ANVISA. Highly committed to implementing effective contract manufacturing, supplier management and Internal audit programs.
Strengths include developing staff, maintaining and developing budgets, implementing robust quality systems, communicating and implementing clear Key Performance Metrics (KPIs), conducting Quality Management Reviews and Executive Reports, implementing Lean Six Sigma programs, influencing and implementing positive change, and leading cross-functional teams.