NIR Implementation in Pharmaceutical and Biopharmaceutical Industry: Technical and Regulatory Considerations

Technical and Regulatory Considerations

Session 109
Regulatory Track

PAT implementation in the Pharmaceutical and Biopharmaceutical industry has gained momentum. There are success stories and there are still some challenges. Practitioners may benefit by exchanging experiences.

Session Description

NIRS emerges as one of the analytical methods that is most widely used in PAT applications. In this workshop, case studies of NIR implementation will be presented and issues related to model development, maintenance and submission will be discussed. Experiences from implementation will be presented along with thoughts on the future of real time release. Both Technical and Regulatory perspectives will be covered.

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

Have an appreciation of the current state of NIRS implementation in the pharmaceutical and biopharmaceutical industry and the technical and regulatory perspectives on the subject

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

Manufacturing/Operations
Product Development
Regulators

Communities of Practice Members that will Benefit

API
Biotechnology
GAMP^®
Good Control Laboratory Practices
Oral Solid Dosage
PQLI^®
Process Analytical Technology
Process/Product Development
Sterile Products Processing

More information on ISPE's Communities of Practice