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ICH Q 12 A New Innovative approach to Product Life Cycle Management

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About the Webinar
ICH Q12 aims to adopt and realize flexible science- and risk-based approaches to post-approval chemistry, manufacturing, and controls (CMC) change management during commercial manufacturing. In this webinar you will learn
Various tools and approaches defined in ICH Q12 to facilitate CMC change management including
Established Conditions (ECs)
Risk-Based Reporting Categories
Product Lifecycle Management (PLCM) Document
Post-approval Change Management Protocol (PACMP)

About Saroj Ramdas
Saroj Ramdas is the Executive Director of CMC Regulatory at Amicus Therapeutics. Saroj has 22 years of experience in drug product development, sterile manufacturing, and CMC regulatory advocacy. She has developed an in-depth knowledge regarding sterile drug product formulation, technology transfer, commercial manufacturing, regulatory documentation, QbD, and accelerated development strategies. She is an active member of various external organizations, including PhRMA, Alliance for Regenerative Medicine (ARM), BioPhorum, BIO, and IQ Consortium (Bio LG). She has been an ISPE member since 2020.
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Management
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