Outcomes that Matter: Benefits of Implementing the Process Validation Lifecycle
As Chair of the 2017 ISPE Process Validation Conference, I am pleased to invite you to join us in Bethesda, Maryland, 12 – 14 September to expand your knowledge of the lifecycle approach to process validation.
In addition to case studies and lessons learned that will be presented by your colleagues, the conference offers multiple benchmarking opportunities and interactive exercises to experience application of the practices discussed.
This event will provide you with insight into implementation strategies to meet new expectations and significant changes in the PV lifecycle approach. You’ll find solutions to your most pressing challenges in the various forums with regulatory leaders and industry experts.This year’s conference will cover all stages in the PV lifecycle approach, and delve into areas that present more significant challenges and opportunities, including:
- Use of science and risk assessment to determine validation strategies, sampling plans, and number of process performance qualification (PPQ) batches during Stage 2
- Regulatory perspectives on the validation of biotech products and on the role of quality risk management in Stage 3
- On-going process validation case study on how to monitor plan development for a large molecule manufacturing process
- Optimization of continued process verification using lean thinking
- Application of the lifecycle approach to process validation in generic and contract manufacturing
- Special presentations for experiences with biotech products, continuous manufacturing, accelerated/breakthrough programs, and packaging process validation
Keynote speakers include:
- 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
Additionally, you can sharpen your process validation statistics knowledge by taking advantage of the 2017 ISPE Process Validation Statistics Conference, which takes place right after the Process Validation Conference. Attendees of both conferences will have access to a networking reception and two concurrent evening sessions on 13 September. Save an additional 25% by registering for both conferences.
For more information and to register, please visit www.ISPE.org/2017-Process-Validation-Conference.
We look forward to seeing you in September!
Sr. Principal Engineer