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Session 1 :Important Considerations in Cleaning Process Development - Beth Kroeger & Richard Chai
Session 2 Biofilm remediation and removal : Paul Lopolito
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
Virtual Conference : Extractable & Leachable considerations for Single-Use components.
A science and risk based approach to Commissioning and Qualification – optimizing the process.
Controlling DI Risks With GMP Manufacturing Software
Regulatory Risk based Inspections
Technology Transfer Essentials for Bio Pharmaceuticals
Leveraging Innovation to Streamline Chemistry, Manufacturing and Controls (CMC) Content and Data in Regulatory Submissions
Microbiological aspects of cleaning validation.
Risk-based Lifecycle Process Development & Validation
Use of Robotics in Sterile Fill Finish.
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).
CLEANROOM COST, QUALITY & ENVIRONMENTAL SUSTAINABILITY
Plans for the Future of Analytical Procedure Development and Validation: Concepts for ICH Q2(R2)/Q14
December 4, 2020