The Calibration & Validation Group
in cooperation with the
Therapeutic Products Programme
present
the millennium event

Workshop on Validation Guidelines

Good Manufacturing Practices (GMP) Guidelines require that all fabricators, packagers/labellers, distributors and importers meet the validation requirements. The purpose of this workshop is to outline and clarify how the Therapeutic Products Programme (TPP) will interpret and apply the validation requirements outlined in the Validation Guidelines entitled "Validation Guidelines for Pharmaceutical Dosage Forms", "Cleaning Validation Guideline" and "Guidelines for Sterile Processes".

The attendees will obtain information about the above mentioned guidelines which will assist them in complying with the validation requirements.

Who should attend? This workshop will be of value to all regulatory, technical and QA/QC personnel who require an understanding of the regulatory requirements concerning validation.

Lecturers
Sultan Ghani, Division of Pharmaceutical Quality, Bureau of Pharmaceutical Assessment, TPP.
Jack Basarke, Bureau of Compliance and Enforcement, Ontario Region, TPP.
Terry Gedz, Division of Pharmaceutical Quality, Bureau of Pharmaceutical Assessment, TPP.
Raymond Giroux, Bureau of Compliance and Enforcement, Quebec Region, TPP.

Organizing Committee
Chung Chow Chan Ph.D., Eli Lilly & Company, CVG
Sultan Ghani, France Dansereau, and Stephane Taillefer, TPP

Meeting Location
Workshops will be held in four cities:

Montreal - September 14
Four Points Sheraton
6600 Cote de Liesse,
Montreal, H4T 1E3,
Tel: 514-344-1999

Toronto - September 16
Le Parc
8432 Leslie Street,
Thornhill, L3T 7M6,
Tel: 416-798-7246

Winnipeg - September 23
Health Protection Branch
510 Lagimodiere Blvd,
Winnipeg, R2J 3Y1,
Tel: 204-983-5490

Vancouver - September 24
Robson Square Conference Centre.
800 Robson Street,
Vancouver
V6Z 2C5,
Tel: 604-660-2830