Event Date/Time: Jun 19, 2006 End Date/Time: Jun 20, 2006
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The greatest gathering of GMP Experts from across the globe addressing the most pressing issues on GMPs from FDA, Health Canada, WHO, ICH, BP, and ISO


- FDA CDER Foreign Inspection Policy & PAI Program
- European Legislation for Traders of APIs and Excipients
- Counterfeit in the API Supply Chain
- GMP-EU Licensing Interface for Substances for
Pharmaceutical Use
- GMP-EU Licensing for Dosage Forms
- Worldwide GMPs for Sterile Medicines and Annex 1 of EU GMP
- Global Cleanroom Standards for ISO TC 209, ISO 14644-1&2
- Update on CDER's Drug Review Processes
- FDA NDA Classifications
- FDA ANDA Drug Review Process
- Health Canada’s Access to Medicines Program and Pre-Exportation Inspections
- Manufacturing and Compounding Drug Products in Canada
- Manufacturing and Regulatory Issues for Biologics in Canada
- On-site Evaluations (OSE) for Approval Process for New Biologics in Canada
- Current GMP Issues and Industry Challenges
- Challenges
- Dealing with Contract Manufacturers
- Outsourcing Regulatory and Quality Functions
- Quality Risk Management and Quality Agreements
- Implementing the CTD, and eCTD

Featuring a panel of 12 prominent speakers:
Betty Cory, PDI
Yogesh Dandiker , Apotex
Gordon Farquharson, UK
Edwin Rivera Martinez, FDA
Karl Metzger , Germany
David Mulligan, Former FDA
Dr. Anthony Ridgway, Health Canada
Dr. Michael Robertson, UK
Dr. Harold Rode, Health Canada
Ms. Sarah Skuce, Health Canada
Roy Thaller, Health Canada
Barbara Zinck, Cambrex

Who Should Attend?

This 2-day conference is directed toward Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biotechnology, Vitamin, Herbal, and allied industries with daily responsibilities in the following areas:

- Quality Control
- Quality Assurance
- Regulatory Affairs
- Product Submission
- Manufacturing
- Validation Services
- Documentation & Technical Writing
- Training
- GMP / GLP Compliance
- Product Submission
- Contract Laboratories
- Consultants
- Contract Manufacturing


Additional Information

Register Early! Spaces are Limited. Attendees are invited for a Wine & Cheese Networking Social June 19th, 2006 6:00 - 7:30 p.m.