Meeting the Quality Standards Bar for Natural Health Products & Dietary Supplements

Venue: Four Points by Sheraton Toronto Airport

Location: Toronto, Canada, Canada

Event Date/Time: Dec 10, 2007 End Date/Time: Dec 11, 2007
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An Interactive Two Day Conference with Dicussions and Updates On:

- Health Canada’s Natural Health Products Directorate
- FDA Expectations and the Dietary Supplement Health and Education Act (DHSEA)
- USP Verification Program for Dietary Supplements
- NSF Update: GMP 9000 Program
- Labelling Requirements
- Therapeutic Claims and Schedule A Prevention Claims
- Categorization
- ID / Characterisation Inspections & Tests
- Master File Procedures
- Site Licensing
- cGMP Practices
- Validation of Analytical Methods
- Evidence for Safety and Efficacy and Quality
- Auditing for Compliance
- Product and Process Development
- NHP Site Licence Application Procedures
- Maintaining the Quality System (inspections, records)
- Food-like NHPs
- Dispute Avoidance Resolution (DAR) Process
- International Trade Certificates
- Manufacturing and Compounding

Distinguished Course Leaders

Ms. Doreen Clark Steen, MA, BA (Biol.),RAC
Director,Regulatory Affairs and Compliance, CMC

Ronald L. Doering BA, LLB, MA, LLD
Partner in the Advocacy Department,
Government Relations and Regulatory Affairs Group

Dale Enright
Innovative Consulting Solutions (ICS)

Dr. Gabriel I. Giancaspro
Director, Dietary Supplements Group
Department of Standards Development
USP (confirmed)

Ian S. Newton
Managing Director
Ceres Consulting

Dr. Regan Tessis
Scientific Reviewer and Regulatory Associate

Anne Ledger Wilkie
Vice-President and Head of Regulatory Affairs & Quality Assurance
Canadian Health Food Association

Brian Thomas Wagner

Edward Wyszumiala
NSF International
Dietary Supplement and Functional Food Program