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Challenges in Analytical Method Transfer
FDA’s KASA Initiative: Criticality of Quality Oversight and Risk Mitigation
Virtual Mini Summit : Rational Formulation Development
Need for OOS investigation and Regulatory outlook
Investigation methodology and investigation tools,
Data to be reviewed for different kinds of OOS results,
Assignable and non-assignable causes
Corrective and Preventive actions
How to write good investigation report.
Tuesday , November 10 , 3.00 pm
Mr. Kamat is currently Global Head of Quality at Dr. Reddy's Laboratories and has 30+ years of experience in leadership roles in the pharmaceutical industry in various leading Indian and International companies in India and the US.
Mr. Kamat holds a Master's degree in Pharmacy and a Diploma in Business Management. He is a member of the International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association and Quality Forum of the Indian Pharmaceutical Alliance (IPA).
Session 1 : Preventive Maintenance on Stainless Steel System by Richard Chai & Paul Lopolito
Session 2 : A Risk Based Contamination Control Strategy by Jim Polarine -
Session 3 : Surface decontamination with VHP – Fundamentals & Facility Integrations by Nicholas Tan & Bruno Aze
Investigating Endotoxin Contamination in Pharmaceutical Water Systems
Expanding Overall Equipment Efficiency Monitoring for Pharma & Biotech
Sanitisation & Biofilms in Pharmaceutical Water Systems