Stacey Bruzzese welcomes Igor Gorsky to the show. Today, Stacey and Igor will be covering the essentials of regulatory guidelines and what goes into writing them.

• Why are the guidelines so important?

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 variety of pharmaceutical facilities. 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.

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