Understanding Regulatory Guidelines with Igor Gorsky

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?
What is the process for developing new guidelines?
What is superior about the lifecycle approach?
Why isn’t complying with Health Authority regulations enough to assure top quality?
What would the industry do without Validation?
What is a good business model to follow in this space?

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.

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.