NHPs & Dietary Supplements

Venue: Crowne Plaza Hotel TORONTO AIRPORT

Location: TORONTO, Ontario, Canada

Event Date/Time: Feb 22, 2011 End Date/Time: Feb 23, 2011
Registration Date: Feb 22, 2011
Early Registration Date: Jan 14, 2011
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About the course
All companies that manufacture, import, and distribute dietary supplements and natural health products must now comply with the GMP rule that holds the manufacturer responsible for the identity, purity, strength and composition of the product.

Manufacturers and importers must establish controls to ensure their products meet these quality standards and to ensure that the raw materials used in their products also comply.

According to FDA’s principal deputy commissioner Dr. Joshua Sharfstein one-third of FDA’s CGMP inspections have found “serious problems.” Among the problems he cited were companies relying on ingredients’ certificates of analysis (C of A) instead of conducting identity testing; failure to have established manufacturing, recordkeeping and quality-control plans; and a lack of end-product testing.

Learn from the experts on how to improve your approach to Identity and Quality testing for GMP Compliance.

Preliminary Program Outline
Understanding the regulation that govern nutraceuticals
Good Manufacturing Practices for Natural Health Products Site License Holders
An In-depth Review of Recent changes to Requirements for NHP Product License Application
Compliance and Enforcement Policy for Industry Stakeholders
Natural Health Products GMPs for Distributors
Natural Health Products GMPs for Importers
Dietary Supplement current Good Manufacturing Practices(cGMPs) and Interim Final Rule(IFR) Facts
Why the NHP Regulations are Good for the Industry
Category Classification of NHPs and Dietary Supplements
Data Protection, Market Exclusivity and Innovation Incentives
Establishing Identity and Quality Testing Programs for Compliance with the Dietary Supplement and NHPD GMPs
Future Direction in NHPs Research and Development
Analytical Challenges in the Certification of Dietary Supplement Standard Reference Materials
Analytical Testing Tools, FDA Guidance and Developments in the New Dietary Ingredient Notification Process
Methods Validation, Quality and Compliance: Resources for a Quality-Assurance Unit
What are Validated Methods: Why are They So Important?
Analyisis of Heavy Metals in Nutraceuticals and Future Requirements
Finished Product Testing for Dietary Supplements: What is Feasible?
In-House versus Official Methods: Is there Room for Both?
Dietary Supplements Analytical Methods Program: A Top Priority for Industry- An Update on Public and Private Initiatives
Establishing Identity and Quality Testing Programs for Compliance with the Dietary Supplement and Natural Health Products (NHPs)
Appropriate Method Selection & Use when Determining Constituents in NHPs
NHP Minimum Testing Requirements
Identify Testing
Microbial Limilts
Elemental Impurities (Heavy Metals) in Nutraceutical and Future Requirements
Potency/ Strength
Stability/ Shelf Life
Detecting Adulteration: Analytical Method Selection & Appropriate Use- Protection Through Testing
Manufacturing, Packaging and Labeling Considerations
Safe Supplements and Athletic Performance
Safety Evaluation for Dietary Supplements and NHPs
Adverse Event Reporting
Qualifying Dietary Supplement Ingredient Suppliers: FDA’s Perspective
Vendor Certification Checklist: How to Qualify Vendors and Agree on Methods for Raw Materials
How to Prepare for and Survive a Dietary Supplement & NHPD Audit