We listened to your requests and the overwhelming feedback from last year’s workshop attendees inspired ISPE to host a second Statisticians Forum on 14 – 15 April 2015 in Silver Spring, MD.

One attendee commented after the 2014 program, “Best conference I’ve been to. Very practical, good material, right on the mark with answering questions and solving problems I face currently, and with a lot of representation from the FDA and opportunities to ask them questions.”

Participants in last year’s Forum gained, not only insight into implementing statistical elements in support of the Lifecycle Approach to Process Validation, but also contributed to the dialogue surrounding the interpretation and expectations from the FDA Process Validation Guidance. We will build on the work and conversations that initiated last year and include topics such as:

  • Global expectations
  • Statistically based quality metrics reporting
  • Sampling plans for Process Validation (PV)
  • Changes in blend uniformity expectations
  • Use of control limits
  • Justifying batches

As an added bonus for those in need of a refresher, a new Statistics Primer Session on Monday 13 April is a pre-conference program designed to serve as a review of statistical concepts and tools including normality tests, utilization of RQL vs. AQL for PV, impact of large non-normality, tolerance intervals and OC curves.

Participants will also delve deeper into statistical analysis with interactive participant polling throughout the event to benchmark Lifecycle to PV implementation.

Lastly, Case Studies will be referenced throughout the conference to illustrate statistical options for each stage of the PV lifecycle.

For more information or to register, please visit the conference website.