If you are involved in a PAT project, or are simply interested in learning more about PAT, this two-part webinar series provides you with an understanding of the fundamental aspects. This first webinar summarizes reasons behind the PAT initiative and provides a comprehensive description of principles and tools. The second session explains how the PAT initiative fits within the broader concepts of Quality by Design (QbD) and Product Quality Lifecycle Implementation® (PQLI®). The course is designed to apply to all types of products within the pharmaceutical industry (including solid dose, parenteral, biotechnology, active ingredients, and drug substances). At the conclusion of this session, participants will be able to:
- Understand reasons behind the PAT initiative
- Describe principles and tools of PAT
- Explain how PAT fits within the framework of QbD and PQLI
Joep Timmermans holds a doctoral degree in Physics from University of Leiden in The Netherlands and a Ph.D. in Chemistry from Princeton University in the U.S. He started his professional career at Merck where he held various positions, including Manager of the Process Analytics group. Joep joined Pfizer in 2002 and currently is Director/Team Leader in Pfizer’s Process Analytical Sciences Group. His team is responsible for the development, evaluation, and initial deployment of new PAT’s and applications throughout Pfizer’s internal manufacturing network. Joep’s team also supports the use of PAT during the commercialization phase of late stage product development. And as of recently, he is leading Pfizer’s initiative to look for opportunities to deploy PAT at CMO’s. He is a Steering Committee member of both the ISPE PAT Community of Practice as well as the Pharmaceutical Process Analytics Roundtable and contributes to other initiatives such as ASTM Committee E55, PhRMA, and PQRI.