Understanding Revised Schedule M Part II Ensuring Compliance in Sterile Product Manufacturing
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- เผยแพร่เมื่อ 2 ก.พ. 2025
- About the Webinar:
With the recent notification of Revised Schedule M by CDSCO, ensuring product quality and compliance has become more critical than ever. To help you navigate these changes, ISPE India Foundation is proud to present this webinar covering key aspects of Part II including : Understanding the fundamental principles underpinning Schedule M Part II,Implementing Good Manufacturing Practices (GMP) for sterile product manufacturing, Addressing challenges ,common pitfalls in compliance and Strategies for streamlining processes while maintaining regulatory compliance and Best practices for documentation, validation, and quality assurance in sterile product manufacturing.
About Mr. Vipul Doshi
Mr. Vipul Doshi has been in pharmaceutical Industry from more than three decades with diverse leadership and operational expertise across development, manufacturing, R&D, GXP quality assurance (QA) and manufacturing operations (parenterals, solid dosage forms, biotechnology, transdermal, biologics and vaccines). He has been a leading advocate for Global Competitiveness and instrumental in due diligence for various acquisitions and mergers. He possesses great expertise in Projects and Engineering for developing Infrastructures for APIs and Drug Products (Sterile and Non Sterile). He has been actively involved with various professional associations like ISPE/PDA/AAM.
Associated with varied Roles and increasing responsibilities he is currently CHIEF QUALITY & COMPLIANCE OFFICER at Zydus Lifesciences Limited (Company has headquarters at Ahmedabad). He also Leads IRA, Research and Development functions for Active Pharmaceutical Ingredient, Environment Health & Safety and Pharmacovigilance.