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June 06, 10.00 am IST

How to meet strict regulatory expectations on containment

Educational Session by Vijay Kshirsagar

How to meet strict regulatory expectations on containment of Penicillins & Cephalosporins?


About the Webinar


Number of pharma companies have been cited by regulatory bodies for inadequate control on contamination with traces of Penicillins or Cephalosporins (β-lactums). The is further high when you have β-lactum manufacturing blocks in the same premises where Non-Penicillin manufacturing blocks too are located. Required awareness is indeed an issue. Be it the traces going into environment or traces present on Non-Penicillin product packs, environment, people, the requirement is very stringent, demanding development of highly sensitive methods and extensive sampling of air/product/ premises along with strict access control and establishing proper acceptable limits. Seminar will concentrate more on how to do rather than what to do?  The presenter is further going to share his very unique experience of converting β-lactum facility into a general block and obtaining regulatory approval for the same which was indeed a very challenging task.


About the Presenter

Vijay Kshirsagar is an accomplished Quality, Regulatory & Analytical professional with around 40 years of rich experience of working for reputed Indian & MNC Pharma firms having represented successfully in US & UK courts on IP related matters.  Presently he is working as Advisor/Consultant to many Pharma companies in India & outside. His last assignment was with Unichem Laboratories, Mumbai  where he worked as  Executive Vice President responsible for CQA, Regulatory & Analytical Research for about 7 years till April 2013 & now working as Advisor on Quality & Regulatory matters.   He is Director on the board of ISPE, India & also the founder President of Society for Pharmaceutical Dissolution Science (SPDS). He has an unique achievement of guiding the company for converting an existing Cephalosporin manufacturing facility into a General product facility & get it approved by regulatory authorities, the task considered as almost impossible by many experts. The work involved extensive decontamination & control studies.