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Course

Montreal

Date:	Name:	Location
Wednesday, April 7, 2010 9:00 AM TO 4:30 PM (Registration 8:30 AM)	CANCELLED Analytical Method Validation, Verification & Method Transfer Presented by the Vice Chair of the USP General Chapters Expert Committee!	Plaza Volare (in the Crowne Plaza Hotel) 6600 Cote-de-Liesse Saint-Laurent, Quebec 514-735-5150
Fees:	Registration Link:	Registration Deadline
PSG Member: $395.00 + $19.75GST = $414.75 Non-Member: $475.00 + $23.75GST = $498.75	Registration for this course is currently closed.	Monday, March 1, 2010
Course Objective:
This one-day course will provide the information you need to ensure validation compliance for your analytical methods and method transfer process. it will include a comprehensive look of the following topics: •Analytical method validation •Differences in approaches to validation experiments, depending on type of method •How and when to implement method verification and transfer procedures •Design of Experiments: how to do them, including how to write validation protocols, establish acceptance criteria and document results
Course Description:
The reliability of analytical data is critically dependent on the validity of the analytical methods and the reliability of the instruments used in the experiments. A systematic approach is required for method verification to ensure that analytical methods perform as intended for their applications. The analytical methods used in drug product development and qualify control applications have to be validated for their intended purpose to meet the regulatory requirements. This one-day course provides the information you need to ensure validation compliance within your organization. By attending, you and your company will obtain these key benefits: 1.Know method validation and verification concepts, requirements and key terminology. 2.Understand regulatory (TPD & FDA) expectations for analytical validation and gain the ICH perspective (ICH Q2) and USP <1225> • Stability Indicating Chromatographic Methods with Degradates/Impurities • Chromatographic methods for Major components • Non-chromatographic methods 3. Discern validation and verification requirements of compendial vs. non compendial methods. 4. Assure proper validation and transfer of analytical methods between laboratories, per TPD and FDA requirements. 5. Assess the impact of validation in your pharmaceutical or biotechnology lab. 6. Know when validation, verification and method transfer apply. 7. Design validation experiments to minimize time and resources 8. Design sensible pre-validation experiments 9. Deal with method adjustments after the method has been validated. 10. Write validation protocols and establish practical acceptance criteria 11. Write validation reports 12. Troubleshoot unexpected results 13. Know the performance requirements and verification tests for chromatographic and spectroscopic methods used in pharmaceutical laboratories.
Course Leader:
Gregory Martin, President of Complectors Consulting Mr. Martin has over 29 years experience in the Pharmaceutical industry. He is President of Complectors Consulting, which specializes in Pharmaceutical Analytical Chemistry, including dissolution, impurities and residual solvents, HPLC method development and validation and cGMP/USP/ICH topics. He is currently Vice Chair of the USP General Chapters Expert Committee and was previously Director of Pharmaceutical Analytical Chemistry at Merck Research Laboratories.
Who Should Attend:
Pharmaceutical professionals in QC, QA, Production, Research, Product Development, Validation and Engineering, who are in a position to manage or execute method validation, verification and method transfer protocols and projects.

Health Canada/Santé Canada • U.S. Pharmacopeia (USP)
Canadian Association of Professional Regulatory Affairs/Association canadienne des professionnels en réglementation (CAPRA/ACPR)