Best Practices: Good Laboratory Practices (GLP)
CLASS SUMMARY
This full day course, led by PharmEng, focuses on the requirements of the Good Laboratory Practice (GLP ) regulations imposed by the Food and Drug Administration (FDA). These regulations will be compared and contrasted to international rules for GLP studies (predominantly OECD regulations).
This interactive presentation encompasses facility and equipment requirements, documentation requirements, roles and responsibilities, plus outsourcing relationships. Practical real world examples are used to emphasize key aspects of the regulations.
A certificate of attendance will be awarded.
REGISTRATION
This session is SOLD OUT and registration is now closed.DATE | TIME | LOCATION
June 3, 20088:00AM - 4:00PM
MaRS Centre
101 College St.
Toronto, ON
OBJECTIVE
This course was designed to improve knowledge and understanding of the requirements of GLP regulations (FDA, OECD). You will also gain insight into assessing current GLP status as well as achieving compliance with GLP regulations in a cost effective manner.OUTLINE
- Introduction; GLP History
- GLP Principles, Terms, Definitions
- ISO vs. GLP
- Management’s Role in Achieving Compliance
- Study Director Responsibility
- Standard Operating Procedures
- Protocols/Study Plans
- Data Quality and Integrity
- Quality Assurance Unit
- Facility Requirements
- Laboratory Operations
- Product Chemistry
- Special Applications of GLP
- Data Auditing/Report Issuance
- Archives/Record Retention
- The Regulatory Inspection Process
AGENDA
8:00 Registration8:30 Introduction and morning session begins
10:15 15 minute break
12:00 mid-day break
1:00 afternoon session begins
2:30 15 minute break
4:00 course & instructor evaluations
ABOUT PHARMENG
PharmEng is a full-service consulting and contract manufacturing company that serves the pharmaceutical, biotechnology and medical device industries in North America and internationally.
Consulting services include:
- Validation
- Engineering
- Product Development
- Lab Instrumentation
- Quality Systems
- Professional Training
- Medical Devices
- Regulatory Affairs
Contract manufacturing services include pharmaceutical support, formulation development, laboratory testing, and the manufacturing of finished solid dosage and liquid products.
ABOUT THE INSTRUCTOR
Yiu-Chung Lee (Y.C.Lee), Ph.DDr. Lee has more than 17 years of pharmaceutical development experience in analytical development, validation, experimental design, drug product specification & stability testing. He is an editor of the book titled “Analytical Method Validation and Instrument Performance Verification” published by Wiley.
Dr. Lee is a founder of the Calibration & Validation Group (CVG), a non-profit organization formed by more than 1,500 analytical and formulation scientists from the pharmaceutical and chemical industries, academia and government agencies across Canada.
Dr. Lee was a Manager in the Lilly Analytical Research Laboratory at Eli Lilly Canada Inc. and was a Director of Analytical Development and Patheon Inc.. His laboratories were responsible for the development of more than 40 new chemical entities (NCE) for global regulatory submissions for commercial production.
Dr. Lee founded PharmLink Inc. at York University in 2005. PharmLink offers comprehensive consulting services to its pharmaceutical clients in compliance and R&D. Recently, PharmLink has joined the PharmEng family to become PharmEng Innovations. Dr. Lee is now a Senior Director of PharmEng Innovations.
MORE INFORMATION
For more information about this event, please email our Events Coordinator at:events@marsdd.com
416-673-8100
Click here for more information about the Best Practices Event Series >>
UPCOMING EVENTS
PAST EVENTS
- October 9, 2008
Best Practices: Is Your Business Model Creative? - June 3, 2008
MaRS Best Practices Series - Good Laboratory Practices - May 13, 2008
MaRS Best Practices Series - From bench top to IND - April 24, 2008
MaRS Best Practices Series - IP Strategies for Medical Devices - April 7, 2008
MaRS Best Practices Series - Doing Business with the National Institutes of Health (NIH): Opportunities for industry - March 29, 2008
MaRS Best Practices Series - How to Draft a Patent Application - March 20, 2008
MaRS Best Practices Series - IP Strategies for Therapeutics - February 28, 2008
MaRS Best Practices Series - IP Strategies for Diagnostics - February 23, 2008
MaRS Best Practices Series - How to Draft a Patent Application - December 12, 2007
MaRS Best Practices Series - Focus on CNS Pharma deals: How to pull in the money - May 23, 2007
MaRS Best Practices Series - Pre-Clinical development workshop - MaRS Best Practices Series - Asymmetric Communications: Building Momentum through Non-Traditional Marketing
- April 11, 2007
MaRS Best Practices Series - Intellectual Property and Valuation of Emerging Medical Therapeutics - November 21, 2006
MaRS Best Practices Series - Business, Science, Technology and You: Financing R&D through Canada’s SR&ED Program - November 9, 2006
MaRS Best Practices Series - Introduction to Systems Biology - September 14, 2006
MaRS Best Practices Series - From Bench to Headline: Translating science for the media - September 8, 2006
MaRS Besst Practices Series - The Power of Pictonics: Using visualizations to tell your technology story - July 12, 2006
MaRS Best Practices Series - Why commercializing a technology is really, really hard to do - May 17, 2006
MaRS Best Practices Series - So what? Who cares? Why you? - April 5, 2006
MaRS Best Practices Series - The move toward drug development - February 11, 2006
MaRS Best Practices Series - How To Draft a Patent Application - February 9, 2006
MaRS Best Practices Series - New Technologies for Accelerating Drug Development
