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Hyatt Regency Bethesda

2015 年 04 月 13 日 7:00 上午 - 2015 年 04 月 15 日 12:00 下午

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

CMC Workshop 2015

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Session 5C: Process Validation/Verification - Biologicals

Session Chair(s)

Kowid Ho, PHARMD

Kowid Ho, PHARMD

Pharma Technical Regulatory Policy

F. Hoffmann-La Roche Ltd, Switzerland

The product life cycle concept was introduced in ICH Q8 and Q10 guidelines. ICH Q11 describes process validation in a life cycle context that can include the collection and evaluation of data, from the process design stage throughout production. These concepts are being implemented in ICH regions. This session will discuss the regulatory expectations and implementation of these concepts in the US and EU.

Speaker(s)

Integration of Control Strategy, Process Validation and Life Cycle Management for Biologics Process Validation

Ronald Bates

Bristol Myers Squibb, US, United States

Implementation of Evolving Process Validation Principles for Legacy Products

Marco Strohmeier, PHARMD

Roche Diagnostics GmbH, Germany

QA Manager

Representative Invited

FDA, United States