This conference provided the current understanding of how industry is implementing statistics in process validation, as well as regulatory expectations through FDA presentations.
- Abhishek Kathuria, Acadia Pharmaceuticals
I am personally passionate about the business benefits that are possible using statistics for lifecycle process validation. As a committee member, I can leverage industry contacts to identify speakers that can provide real-life examples of these benefits. I can also be part of the learning activities that build statistical thinking, and expand the “voice” beyond the speakers.
Speakers provided alternative approaches to the classical methods of risk assessment, statistical modeling, and a “one size fits all” approach to monitoring. There was further evidence provided of an increasing use of patient risk as a prime criterion for decision making. I will refer to this evidence in the advice I provide.
- Tara Scherder, Partner, SynoloStats
The real world case studies shared made the conference eye opening. The opportunity to discuss details and network with peers made the events invaluable.
- Jenn Walsh, Director, Robustness & Validation, Bristol-Myers Squibb