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Validation Life-Cycle Management (LCM) of Analytical Procedures According to FDA, ICH and USP Requirements

4239
Duration : 90 Minutes

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.  Since 2003, she has provided consulting and training services to pharmaceutical companies, including companies ope Read more


New medicines are developed every day to meet medical needs and improve quality of life. Analytical procedures are used to establish acceptance criteria and monitor quality of drugs. The development of pharmaceutical products is an evolution through clinical phases and it is also carried into commercialization. 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.  A discussion of life-cycle management of analytical procedure will also be discussed with an update of new validation regulation.

This live training webinar will introduce regulatory requirements from FDA, ICH and USP, discuss the highlights of different validation parameters and how to manage the change throughout the drug development process to stay in compliance.

Course Objectives:

Upon completion of this session attendees will learn key factors that would affect validation process of analytical procedures. One must understand validation characteristics and able to determine when re-validation would need to be conducted. 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
• Regulatory requirements from the FDA
• Reviewing ICH and USP validation
• Validation characteristics
• When re-validation is needed
• Verification vs. Validation

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Analytical chemists
• Compliance managers
• Lab managers
• Quality Control Personnel
• Quality Assurance Personnel
• Validation Personnel
• Research & Development
• Auditing Personnel
• Regulatory Affair Personnel
• Manufacturers of raw materials and ingredients
• Regulatory scientists, and individual personnel, who are working in pharmaceutical development.

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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