FDA Expectations on Analytical Life Cycle Management of Method Validation

Location: Attend Live Webinar
Date: 05-Mar-2015: 10:00 AM PST
Duration : 90 Mins

Speaker: Kim Huynh-Ba

Kim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences.  She currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003.

Course Description:

Analytical procedures are critical tools to control and monitor quality of pharmaceutical products. Therefore, method validation is very important to ensure that analytical procedures performed according to their intended use.

The development of pharmaceutical products is an evolution through clinical phases and it is also carried into commercialization.

In February 2014, the FDA issued a draft Guidance for Industry on “Analytical Procedures and Methods Validation for Drug and Biologics” to include life cycle management.

Course Objective:

This webinar will provide a summary of FDA expectations of method development and validation, content of analytical procedures, concept of method re-validation and verification and introduce the key concept of life cycle management (LCM) of analytical method through drug development.

Course Outline:

• Objective of analytical testing

• Principles of method validation

• Key factors of analytical method development

• Important sections of analytical procedures

• How to manage procedures through product life cycle

• Expectation of method verification

 Target Audience:

This session will benefit 

• Analytical chemists

• Quality control scientists

• Managers

• Directors

• Quality Assurance professionals

• Regulatory affairs

• Researchers who are involved with the development and validation of analytical procedures for pharmaceutical products

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Thank you & Regards,

Kevin Roberts,

Training Manager,

kevin.roberts@complianzworld.com

Call us at this Toll Free number: +1-866-978-0800

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