WCDG & AOAC-SCS Joint Two-Day Regulatory & Compliance Conference , Nov. 5–6, 2009

 Strategies and Challenges for Raw Materials Qualification in Pharmaceutical Product Development

 Overview of the Pharmacopeial Discussion Group: Harmonization from a Compendial Perspective 

 Good Storage and Shipping Practices for Drug Products

 Aggregates in Therapeutic Protein Products 

 Extractable/Leachable Testing & Regulatory Requirements for Ophthalmic Dosage Forms

 USP's Elemental Impurities Initiative - Current Status 

 Heavy Metals Update

 Impurity Profiling 

 The Evaluation of Impurities in Investigational New Drug and New Drug Applications

 What Does Quality By Design Bring to your Drug Development Program? 

 Biological Raw Material Contaminants

AOAC / WCDG meeting , May 7–8, 2009

 Understanding DS cGMP Requirements for Testing

 Assuring the Quality of Dietary Supplements and Functional Ingredients 

 Microbiology Challenges Under New Dietary Supplement GMPs 

 Qualify 3rd Party Lab and Understand Conflicting Lab Results 

 Detection of Pharmaceutical Drugs & Related Analogues in Dietary Supplements 

 Canadian Regulatory Requirements for Natural Health Products: An Industry Perspective 

 Approaches to Regulating Dietary Supplements and their Claims 

  Ensuring a Method is Ensuring a Method is "Fit for Purpose Fit for Purpose" 

Inaugural Research Symposium, April 20-21, 2009

USP WCDG Meeting Agenda, March 6, 2009

GMP / Auditing in Pharmaceutical Industries, December 4–5, 2008

Agenda      

Registration Form 

Implementation of the Residual Solvents Requirement 

Responding to FDA-483 Observations 

How FDA Determines Who to Hold Accountable for Violations 

DEVIATION INVESTIGATIONS 

USP Residual Solvents, Glycerin Monograph, and More! 

Winning Inspections 

AOAC Meeting Agenda 

Lessons to be learned from recent scandals: FDA cannot do anything. 

USP Course, TLC for Dietary Supplements: Botanicals, November 5–6, 2008

USP Compendial Discussion Group Presentations, August 1, 2008

Modified Light Obscuration, Method of Subvisible Particle, Quantification of Protein Therapeutics     

Current USP Approaches to Biologics Issues 

Interpretation of the New USP General Chapter <467> Residual Solvents 

Pharmacopeial Monographs for Biotechnology Products 

USP/FDA Joint Two-Day Regulatory & Compliance Conference, April 24 – 25, 2008

Agenda      

Registration Form