February 18, 2021


60-75 minutes


10 AM PST/1 PM EST/11:30 PM IST


Advanced Professional

Why should you attend?

Increasing political and social pressures are forcing Life Sciences companies to manufacture affordable drugs that meet the existing requirements of patient safety, product quality and data integrity. Consequently, regulatory agencies are encouraging companies to meet these objectives through changing regulations that leverage progress in science and technology.

Over the years, auditors began to realize that the industry believed that producing voluminous documentation in support of validation would impress them. During their audits they noticed that often times companies lacked an understanding of the systems they were validating, thereby defeating the very purpose of validation. The new CSA approach being proposed focuses on critical thinking to obtain a good understanding of system risks, and the prevalent ways to mitigate them through validation.

This presentation will focus on applying CSA to the design, development and validation of a Manufacturing Automation System. The system operates in a multi-tiered functional hierarchy consisting of PLC’s, DCS and MES. The system realizes flexible manufacturing in a multiproduct facility where re-validation is not required for product changeovers.

Areas covered:
  • Regulatory expectations of CSA
  • Fundamental differences between CSV and CSA
  • The what and why of Flexible Manufacturing Systems
  • Why the validation of Manufacturing Automation Systems (MAS) is a challenging task
  • The regulations that MAS must satisfy
  • How applying CSA to MAS satisfies data integrity requirements
Who will benefit?
Professionals across:
  • Quality Assurance/ Quality Control
  • Product and Process Development
  • Validation
  • Manufacturing Operations
  • Engineering
  • Regulatory Affairs
  • Automation Engineers

Instructor Bio

Chinmoy Roy is a biopharmaceutical consultant with over 38 years of experience in CSV, Data Integrity, 21 CFR Part 11, Annex 11 and manufacturing process automation. He is a member of ISPE’s Data Integrity Special Interest Group (S.I.G) and is a Senior Industry consultant for ValGenesis Inc.. He has worked for and consulted with several companies including Genentech, Roche, Bayer, Novartis, Gilead, and others. He travels the world to train industry personnel in the areas of his expertise, as well as to conduct data integrity audits. Chinmoy has a bachelor’s degree in Electrical Engineering and a Master’s Degree in Computer Science. He lives in the San Francisco Bay area.

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