These conferences are invaluable due to the breadth of process validation lifecycle challenges addressed and the opportunity to interact with experienced and leading practitioners and regulatory experts.
Bethesda, Maryland (PRWEB) July 26, 2017
The International Society for Pharmaceutical Engineering (ISPE) will host its 2017 Process Validation and Process Validation Statistics Conferences in Bethesda, Maryland, 12 – 15 September. These concurrent events offer comprehensive solutions to process validation lifecycle challenges faced by process validation professionals and statisticians today.
“These conferences are invaluable due to the breadth of process validation lifecycle challenges addressed and the opportunity to interact with experienced and leading practitioners and regulatory experts,” said John Bournas, ISPE CEO and President.
Designed to expand attendee knowledge of the many facets of process validation, these back-to-back events cover the entire Process Validation Lifecycle - from Stage 1 Process Design through Stage 3 Continued Process Verification (CPV). Benchmarking opportunities abound through shared real-world experiences of successes and challenges from presenters and fellow professionals.
- Zhihou "Peter" Qui, PhD, Branch Chief, Division of Inspectional Assessment, FDA/OPF/OPQ/CDER
- Ranjani Prabhakara, PhD, Team Leader, Office of Compliance, Division of Drug Quality II, FDA/CDER/OMQ
Featured FDA Sessions:
- FDA Perspective on Process Validation for Biotech Products
- Stage 3 Process Validation and Quality Risk Management Procedures: ICH Q9
- Kit Roes, PhD, Professor of Clinical Trial Methodology, University Medical Center Utrecht and Observer in the EMA Biostatistics Working Party
Featured FDA Sessions:
- Application of Statistics in the Process Validation Lifecyle
- Considerations for Continuous Manufacturing Implementation throughout a Product Lifecycle: FDA Perspective
Attendees of both conferences will have access to two concurrent evening sessions, a half day regulatory session, a networking reception, and a registration discount.
To learn more or to register for these events, visit http://www.ISPE.org/2017-Process-Validation-Conference and http://www.ISPE.org/2017-Process-Validation-Statistics-Conference.
The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical life cycle. The more than 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland USA, and an operations and training center in Tampa, Florida USA. Visit http://www.ISPE.org for more information.
For more information contact:
Senior Director, Marketing Communications
International Society for Pharmaceutical Engineering (ISPE)