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THIS SHORT COURSE HAS BEEN CANCELLED.
Sunday, 16 November, 8:30am - 1:00pm
Cost: $299
Where: Room 308, Philadelphia Marriott Downtown
Instructors/Speakers: Charles Hoiberg, John Lepore, Stephen Tyler, and John Groskoph
Professional Development Hours: 4. Participation in this AIChE short course may qualify as CPC in certain jurisdictions. Attendees will receive a signed Professional Development Hours certificate at the end of the course.
Overview:
This ISPE short course provides practical information on how the whole approach to product and process development of pharmaceutical products is changing via Product Quality Lifecycle Implementation. PQLI is an industry driven initiative designed to develop a practical and pragmatic approach to implementing Q8, Q9, and Q10, and related ICH ( International Conference on Harmonization ) Guidance Documents. This process requires engineering involvement in the early development of products and processes and the integration of science and engineering with quality systems.
Based on sound scientific, engineering, and business principles, PQLI provides a technical framework for the implementation of Quality by Design (QbD). It helps to craft a pragmatic approach to implementing Q8, Q9, and Q10, using a risk-based approach to the lifecycle of a product from regulatory submission to end-of-life migration. The PQLI approach involves working with industry and regulatory leaders worldwide in the development and implementation of this critical thinking.
Presenters will cover interests in the global industry, regulatory, and academic communities:
Time |
Course Schedule |
08.30-09.30 |
Introduction, Regulatory, and PQLI Background (Hoiberg) |
09.30-10.15 |
Design Space to Criticality (Lepore) |
10.15-10.45 |
Break |
10.45-11.30 |
Control Strategy (Tyler) |
11.30-12.15 |
The Role of PAT (Groskoph) |
12.15-12.45 |
Questions and Answers with Speaker Panel |
12.45-13.00 |
Summary and Adjourn |
About the Speakers:
Charles Hoiberg, PhD, is an Executive Director in Pfizer's Reg CMC - Policy and Regulatory Environment group. He received a PhD in biochemistry from the Pennsylvania State University and worked for more than eight years at Sterling Drug, Inc., in R&D before joining the FDA. Dr. Hoiberg held numerous positions in the Agency and was involved in global initiatives retiring as the deputy director of the Office of New Drug Chemistry and the associate director for International Activities and the CDER ICH quality coordinator. Representing the Agency in the negotiations of many ICH topics, he has had close contacts with many worldwide regulators and industry leaders. Dr. Hoiberg has been a frequent lecturer for ISPE at its domestic and international programs in Europe and Asia. He is currently the Vice Chair, ISPE International Board of Directors.
John Lepore, PhD, is Senior Director, Commercialization, Merck & Co., Inc., USA. Dr. Lepore leads API process development for Merck synthetic compounds and is responsible for process definition/optimization, manufacture of API used in clinical trials, and technical transfer of process knowledge to the Merck Supply Organization. During his 18-year career with Merck, he led the API launch of seven products, operation of pilot plant facilities at Rahway, and the compliance function, including safety, environmental, and GMP areas. With an in-depth knowledge of drug development and process and product economics, Dr. Lepore is a regular instructor for training of FDA staff (ORA), and a guest lecturer at both the University of Michigan (Pharmaceutical Engineering Program), and Rutgers University (Lerner Center for Pharmaceutical Management Studies). He serves on the ISPE PQLI Technical Steering Committee and is Chair of the Design Space Task Team. He is also a member of the Development Technical Committee for the Product Quality Research Institute (PQRI). He received a PhD in chemical and biochemical engineering at Rutgers University.
Stephen Tyler is Director of Strategic Quality and Technical Operations in Global Pharmaceutical Operations, Abbott Laboratories, USA. Tyler joined this division of Abbott Laboratories in 2008. Previously he was director of process sciences and engineering, and provided technical support to Abbotts drug product and substance manufacturing organization. He joined Abbott in 1984 and has been there for 23 years acquiring process development, manufacturing, and management experiences. The Strategic Quality and Technical Operations group provides strategic centralized technical support for data analysis, quality technology transfer, risk assessment and management, and development of enhanced quality systems. He holds a B.S. in applied biology from the Georgia Institute of Technology, an M.S. in microbiology from the University of Georgia, as well as a B.S. in chemical engineering from the Georgia Institute of Technology.
John Groskoph is Director New Products CMC, Global Chemistry Manufacturing and Controls at Pfizer, Inc. Groskoph has more than 17 years of pharmaceutical industry experience with a particular focus on CMC regulatory compliance. During his career at Pfizer, he worked in a variety of quality operations and production assignments and brings experience in quality and compliance systems, post-approval change management, and regulatory strategy. He joined the manufacturing control department in1998 as manager, manufacturing control. He was appointed director, global manufacturing compliance in 2001. In 2002, he took a one-year assignment in the Arnprior, Canada plant where he held various responsibilities in both the quality and manufacturing teams. Prior to his current position, Groskoph held the position of team leader, quality compliance programs at the Parsippany, New Jersey manufacturing site. Groskoph holds a BS in electrical engineering from Lafayette College, Pennsylvania and an MBA from Columbia University, New York.