Lifecycle Approach to Process Validation

Описание: Lifecycle Process Validation guidance has been published by FDA in 2011 and by PIC/S and EMA in 2015. This guidance reflects ICH guidance on enhanced development and product quality monitoring practices using approaches based on Quality by Design.
In this webinar
Learn how science and risk-based principles can be applied across the process lifecycle
Discover the QbD roadmap – from QTPP to Control Strategy
Learn the role and significance of Control Strategy in the PV lifecycle, and how it evolves from development to commercial manufacturing
Understand how PV Stage 2 depends on information from Stage 1 and the link to Stage 3.
Understand the process validation lifecycle and the importance of maintaining an effective pharmaceutical quality system
Understand how data is used to connect the stages and assure ongoing product quality
Learn how Continued or Ongoing Process Verification during the production of commercial produce ensures the process designed and qualified/validated continues to deliver consistent quality.
Presenters:
Tara Scherder has over 20 years of experience in the pharmaceutical and biopharmaceutical industries as a statistician, process engineer, and master black belt. She has functioned as both an in-house and external statistical consultant to drug substance and drug product teams from product development through commercial supply for the spectrum of product platforms. She frequently speaks at industry forums and publishes on the practical incorporation of statistical methods for Lifecycle Process Validation.
Mr. Doshi is Senior Validation Manager at Anika Therapeutics in Bedford, Massachusetts. He has over 15 years of experience in managing validation, metrology and engineering programs in the biopharmaceutical and medical device industry. His experience includes validation of processes, equipment, single-use systems, utilities, computerized systems, cleanroom facilities, cleaning, labeling, packaging and cold chain shipping. He is currently on the ISPE Process Validation committee.