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Re-validation: When Is It Necessary

This quick reference guide discusses what is re-validation and the need to do it. For more details visit us at:http://www.complianceonline.com/eliminate-the-confusion-analytical-method-qualification-and-validation-webinar-training-702314-prdw?channel=vslideserve

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Re-validation: When Is It Necessary

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  1. Re-validation: When Is It Necessary

  2. What is Re-validation? Re-validation include: Testing Documentation Training Disaster Planning SOPs Qualifications Approvals

  3. Life Cycle of Analytical Methods Change of products Validation Re-validation Change of analytical methods

  4. Why Revalidate? Possible causes of analytical method change that warrant method revalidation: • Synthetic process change • Formulation change • Out‐of‐Specification investigation • Specificity problem (e.g., new impurity) • Ruggedness issue • Post approval changes

  5. A Daily Question…Do I need to “Re‐validate”? Something changed, what do I need to do to be compliant?

  6. Want to learn more about analytical method validation, FDA requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links: • ICH, FDA and USP Requirements for Method Validation • How to Validate Analytical Methods and Procedures • Validation of Analytical Methods and Procedures • Eliminate the Confusion - Analytical Method Qualification and Validation • Lifecycle Approach to Analytical Methods with QbDElements • Analytical Instrument Qualification and System Validation • Lifecycle Approach to Analytical Methods for Drug Products

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