Meeting the Quality Standards Bar for Natural Health Products & Dietary Supplements
Event Date/Time: Dec 10, 2007 | End Date/Time: Dec 11, 2007 |
Description
- 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
- HACCP
- 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
CanReg
Ronald L. Doering BA, LLB, MA, LLD
Partner in the Advocacy Department,
Government Relations and Regulatory Affairs Group
Gowlings
Dale Enright
President
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
Dicentra
Anne Ledger Wilkie
Vice-President and Head of Regulatory Affairs & Quality Assurance
Canadian Health Food Association
Brian Thomas Wagner
President
NHPConsulting
Edward Wyszumiala
NSF International
Dietary Supplement and Functional Food Program