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Podcast: Voices In Validation
Episode:

Principles of Parenteral Solution Validation
Category: Science & Medicine
Duration: 00:58:50
Publish Date: 2021-04-06 04:00:00
Description:

This week, Stacey is joined by Igor Gorsky, author of Principles of Parenteral Solution Validation, A Practical Lifecycle Approach. Stacey and Igor discuss the history of Parenteral Process Validation and why the resources in this manual are so important in this day and age.

 

Resources from this episode:

Principles of Parenteral Solution Validation: A Lifecycle Practical Approach written by Igor Gorsky and Harold Baseman, published by Elsevier

Process Validation: General Principles and Practices - FDA

ICH guidance Q8 Pharmaceutical Development published May 2006

Q&A for the current working procedure for implementing the Q8, Q9, and. Q10 guidance's

Slides referenced by Igor

 

Igor is the principal consultant at Valsouce Inc. He also is a Pharmaceutical and Biotechnology Industries’ Leader with broad strategic and tactical leadership experience spanning Development, Commercial Manufacturing, and Quality organizations. Proven record in implementing Validation Master Plans based on Risk Management and principles outlined in ICH Guidances Q8, Q9, Q10, and Q11 in a variety of pharmaceutical facilities. Expertise in implementing Quality by Design in the manufacturing environment throughout commercial product launch. Proven track record in building Validation organizations, establishing and implementing validation policies and training programs. Direct personal interface with FDA, MHRA, ANVISA, and other regulatory organizations.

 

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out the website at http://ivtnetwork.com.
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