Expanding Your Knowledge of the Lifecycle Approach to Process Validation
It’s hard to believe that another summer has come to an end, but that also means the 2017 ISPE Process Validation Conference is right around the corner! Our theme is “Outcomes that Matter: Benefits of Implementing the Process Validation Lifecycle”. We have several great industry speakers who will be sharing their experiences, case studies, and lessons learned across the three stages of the Process Validation Lifecycle. We will also be exploring how the lifecycle has been applied to accelerated/breakthrough programs, continuous manufacturing, and packaging.
Along with industry presenters, I’m very pleased to confirm that we have two presentations from the FDA: “FDA Perspective on Process Validation for Biotech Products” and “Stage 3 Process Validation and the Role of Quality Risk Management”.
In addition to learning from industry and regulatory colleagues via presentations, I really enjoy all of the interaction with other attendees during the conference. It’s always great to chat with someone that may have experienced a similar problem to one that you’re currently dealing with and getting some insights from them on what might or might not work.
As with previous years, we will continue the tradition of benchmarking sessions so we can all learn from each other on current hot questions. We will also have two interactive group exercises. Last year’s group exercise was not only educational, but a lot of fun, and the feedback from attendees was very favorable. So, this year, we will have one on each day.
The first one will examine how we use development and Stage 1 data to design our Control Strategy that will be confirmed in Stage 2. On the second day, we will look at how heightened monitoring and testing decisions might be made during Stage 3a. For each of these exercises, we have very dynamic facilitators, and I expect these to be a highlight of this year’s conference.
Additionally, if you’re interested in attending the ISPE Process Validation Statistical Conference that immediately follows on 14 – 15 September at the same location, you can get an additional 25% discount by registering for both conferences. This will also give you access to a networking reception on the evening of 13 September.
For more information and to register, please visit the conference website.
Hope to see you all in Bethesda in September!
By: Brad Berkowicz
Sr. Principal Engineer