2005 FDA cGMP China Training Program
December 5-7, Bejing, China

The U.S. Food and Drug Administration, Peking University, and ISPE are co-sponsoring a training program to provide the latest updates from the FDA on current regulations and guidances, and interactive training workshops on oral solid dosage, and API manufacturing.

• Federal Register Notice [TXT] [PDF]
• Program Information  Program flyer
• For registration information, please contact Mark Stefko at ISPE, (813) 739-2287
• Presentations (12/14/2005)
  • FDA Overview [PowerPoint]
  • Solid Oral Dosage Forms, [PowerPoint] Nicholas Buhay, CDER
  • cGMP in the USA, [PowerPoint] Nicholas Buhay,CDER
  • Counterfeit Drugs, [PowerPoint] Nicholas Buhay, CDER
  • FDA cGMP Inspections, [PowerPoint] Robert C. Horan, Ph.D., CDER
  • FDA API Inspections, [PowerPoint] Robert C. Horan, Ph.D., CDER
  • The FDA Process for Approving Generic Drugs [PowerPoint]

Links to Related Information

• Center for Drug Evaluation and Research  http://www.fda.gov/cder/
• Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach  http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm
• Guidance for Industry - Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations http://www.fda.gov/cder/guidance/6452dft.htm
• Division of Manufacturing and Product Quality - GMPs (HFD-320) http://www.fda.gov/cder/dmpq/index.htm
• Current Good Manufacturing Regulations (GMPs): 21 Code of Federal Regulations
  Parts 210 and 211 http://www.fda.gov/cder/dmpq/cgmpregs.htm
• Drug Manufacturing Inspections Program 7356.002 (how FDA conducts inspections of drug firms) http://www.fda.gov/cder/dmpq/compliance_guide.htm
• cGMP-related Guidance Documents http://www.fda.gov/cder/guidance/guidance.htm#CGMPs
• Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs http://www.fda.gov/cder/guidance/cGMPs/default.htm
• FDA Compliance Policy http://www.fda.gov/ora/compliance_ref/default.htm (an extensive list of resources, including:)
  • Compliance Program Guidance Manual (CPGM) Compliance programs and program circulars (program plans and instructions) directed to field personnel for project implementation.
  • Compliance Policy Guides (CPG) Contains FDA compliance policy and regulatory action guidance for FDA staff.
  • Regulatory Procedures Manual (RPM) Contains FDA regulatory procedures for use by FDA personnel.

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Date created: August 31, 2005, updated December 14, 2005

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