Good Manufacturing Practice Inspections: What Govt. Agencies Look For

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, Oct 16, 2018
90 minutes
Product Description

Pass Muster with GMP Regs in the U.S., Europe, and Japan

Good manufacturing practice (GMP) is a must for manufacturers of finished pharmaceutical products and active pharmaceutical ingredients. While GMP rules are somewhat internationally harmonized, you don’t want to be caught off guard as you move from one jurisdiction to the next. Instead, you’d better be prepared to satisfy the FDA, the EMA, and the PMDA.

Pharmaceutical industry expert Angela Bazigos details GMP requirements for the United States, European Union, and Japan in this information-packed webinar. Bazigos runs down the current status of harmonization and future trends, and shows where conflicts in the rules of enforcement agencies—the U.S. Food & Drug Administration (FDA), European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)—can become a problem.

The U.S., Europe, and Japan established ICH Q7 to harmonize inspections, but the reality is that inconsistencies remain. Attend this live audio event to learn about typical audit agendas, ICH area differences, compliance with ICH guidelines for GMPs, and the auditing of finished products. Bazigos will also explain excipients, sterile products, biologics, and clinical packaging. GMP can’t be ignored for companies bringing products to new markets.

Session Highlights

Topics covered in this webinar include:

  • Harmonization and future trends in GMPs for the U.S., E.U., and Japan
  • Discrepancies in global expectations and alignment issues
  • Key chapter reviews
  • Compliance with ICH guidelines for GMPs
  • Auditing API facilities and a typical audit agenda
  • Finished products
  • Excipients and sterile products
  • Clinical packaging
  • Area GMP inspections
  • Auditing your facilities for global considerations

Who Should Attend

  • Manufacturing officials
  • Quality control officers
  • Quality assurance personnel
  • Senior management
  • Project managers
  • Qualified persons
  • Regulatory compliance personnel
  • CMC personnel
  • Packaging experts
  • Auditors and staff
  • IT subject matter experts

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Angela Bazigos - Pharma Conferences

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers & Public Health Services companies. Positions include Chief Compliance Officer at Morf Media, Director of QA,...   More Info
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