Process Validation: A Lifecycle Approach with Biotech Applications (Q11)

Session 403
Regulatory Track

Application of lifecycle approach to PV as outlined in the FDA PV Guidelines can be especially complex for Biotech drug substance manufacturing due to level of variability in raw materials, number of CQAs in the finished drug substance and subsequent drug product, lack of accessibility to sample equipment, assay variability, etc. Very few examples are currently available.

Session Description

Industry and regulatory representatives will discuss application of the lifecycle approach to Process Validation for Biotech drug substance and drug product manufacturing. Most significant issues, challenges and ideas for practical implementation will be discussed.

At the conclusion of this session, participants will be able to:

Identify areas of focus and prioritize implementation efforts for the lifecycle approach to implementation
Explain implementation of the lifecycle approach to PV as a tool to assure supply reliability and product quality
Understand the impact of recently approved ICH Q11 on registration and process validation
Benchmark implementation status progress with other participant companies
Provide input to selection of future areas of focus for ISPE PQLI PV efforts

Leaders

Speakers

Jeff Campie, USA
Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
Edwin Melendez, Principle Consultant, Parexel, USA
Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
Julian Wilkins, Vice President, PharmaConsult US Inc, USA
Paul Wreglesworth, Independent Consultant, United Kingdom

Who Should Attend

Validation professionals
Biotech manufacturing professionals
Quality Assurance professionals supporting Biotech manufacturing
Regulators supporting Biotech manufacturing

Communities of Practice Members that will Benefit

API
Biotechnology
Investigational Products
Operations Management
PQLI^®
Process Analytical Technology
Process/Product Development
Project Management
Sterile Products Processing

More information on ISPE's Communities of Practice