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	Podcast:		Voices In Validation
	Episode:		Science and Risk-Based Cleaning Validation. GMPs for the 21st Century.
	Category:		Science & Medicine
	Duration:		00:59:36
	Publish Date:		2020-09-15 04:04:00
	Description:		This week, Stacey is joined by Igor Gorsky, Senior Consultant Val Source Inc. Stacey and Igor discuss current restrictions and guidelines for cleaning, the shift to more science risk-based approach, streamlining the cleaning process while assuring patient safety and product quality. Igor is an industry leader in Pharmaceutical and Biotechnology with broad strategic and tactical leadership experience spanning Development, Commercial Manufacturing, and Quality organizations. He has a proven record in implementing Validation Master Plans based on Risk Management and principles outlined in ICH Guidances Q8, Q9, Q10 and Q11 in variety of pharmaceutical facilities. Igor brings expertise in implementing Quality by Design in 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 their website at http://ivtnetwork.com.
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