As Co-Chairs of the 2017 ISPE Process Validation Statistics Conference, we are pleased to invite you to join us in Bethesda, Maryland, 13 – 15 September as we explore evolving and state-of-the-art approaches to implementing statistics in process validation.

This exceptional forum has become a converging point for statisticians and those skilled in the use of statistics to reflect on past practices, discuss current trends, and consider future challenges. You’ll have the opportunity to interact with regulatory experts and leading practitioners as they share their current thoughts on the relationship of statistics, validation decisions, and patient risk.

You will also actively participate in discussion groups exploring current challenges chosen by attendees, and an open forum session on the recent EMA reflection paper on comparability assessment of quality attributes. Dr. Kit Roes, University Medical Center Utrecht, will provide additional insight into this effort in his keynote address.

This year’s Conference will expand your knowledge on:

• Regulatory perspectives on the application of statistics in the PV lifecycle
• Leveraging the Control Strategy during Continued Process Verification (CPV)
• Quality by Design (QbD) approach in analytical method development and validation
• Statistical approaches for process parameter criticality assignment in Stage 1
• Opportunities and challenges for statisticians in risk assessment throughout the product lifecycle
• Statistical considerations for contract manufacturing

You can also sharpen your process validation knowledge by taking advantage of the 2017 ISPE Process Validation Conference, which takes place right before the Process Validation Statistics Conference. Save an additional 25% by registering for both conferences.

For more information and to register for the 2017 ISPE Process Validation Conference, please visit the conference website.

We look forward to seeing you in September!

Best Regards,

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