AUGUST 31, 2007

Chairs: Prof. Dr. Michael Anisfeld (USA) and Prof. Dr. Wenfang Xu (CHINA)

Registration: 8.00 - 9.00 a.m.

ADVANCED GMP CONCEPTS
9.00 - 10.30 a.m.

• Current international GMP developments
• GMPs for the 21st Century

Coffee Break: 10.30 - 11.00 a.m.

• Current Developments in Systems and Risk Based Inspections
  
• Risk Analysis / Risk Management
  
• Effective CAPA systems
  

Lunch: 1.15 - 2.15 p.m.

ADVANCED GMP CONCEPTS
2.15 - 3.45 p.m.

• Regulatory GLP and GMP Issues
• Creating Documents That Help Users Work Right
• ISO 9000 and Documentation - Differences to GMP Requirements

Coffee Break 3:45 - 4:15 p.m.

4.15 - 6.00 p.m.

• Batch Production and Packaging Records
• What Regulatory Inspectors Look For In Documents and Documentation Systems
• Determining Who Should Approve Documents
• Electronic Records and Electronic Signatures
  - Essential Elements that Must Be in Place to Comply with 21CFR11 / EU Annex 11 Regulations and Requirements

SEPTEMBER 1, 2007

Chairs: Prof. Dr. Michael Anisfeld (USA) and Prof. Dr. Wenfang Xu (CHINA)

CAPA: EFFECTIVE INVESTIGATIONS AND CORRECTIVE ACTIONS

GMP requirements for failure investigation in the US, EU, and Canada
9.00 - 10.30 a.m.

• How do the GMP authorities want you to investigate failures and quality events?
• Key Considerations in effective “Root Cause” and CAPA Analyses

Coffee Break: 10.30 - 11.00 a.m.

11.00 - 1.15 a.m.

• Out-Of-Specifi cation (OOS), Out-Of-Trend (OOT), Out-Of-Expectations (OOE)
• Tools for Effective Investigations

Lunch: 1.15 - 2.15 p.m.

MANAGING THE QC LABORATORY IN A GMP COMPLIANT MANNER
2.15 - 3.45 p.m.

• Laboratory Management
• Laboratory Analyst Training
• Analytical Method Development, Validation and Transfer

Coffee Break: 3:45 - 4:15 p.m.

4.15 - 6.00 p.m.

• Reference Standards
• Effective use of the United States and European Pharmacopoeias
• Instrument Calibration And Qualification