ISPE 2016 Process Validation & Process Validation Statistics Conferences

Conference Essentials

Registration Hours

  • Monday, 24 October 07.00 – 17.00
  • Tuesday, 25 October 07.00 – 20.00
  • Wednesday, 26 October 07.00 – 17.00
  • Thursday, 27 October 07.00 – 17.00

* Bring your mobile devices so you can participate in interactive benchmarking and Q&A sessions, using the Pigeonhole application.


Must-Attend Events & Sessions

  • Welcome Reception
    Tuesday, 25 October 17.30 – 18.30
    Network with your industry peers and conference speakers at the Combined Welcome Reception for Process Validation and Process Validation Statistics Conference attendees.
  • Special Sessions at Process Validation Statistics Conference:
    Primers for Statisticians, Non-Statisticians, and Beginners
    Tuesday, 25 October 2016
    18:30 – 22:00

    • Statistical Tools for Process Validation for Statisticians – Controversial Topics
      James Bergum, PhD, President BergumSTATS, LLC
    • Statistical Tools for Process Validation for Non-Statisticians
      Kimberly Vukovinsky, Senior Director – Statistics, Pfizer Inc.
  • New! Combined Regulatory Session
    This year’s conference will feature a half-day of Combined Regulatory Session for Process Validation and Process Validation Statistics attendees on 26 October, 08.30 – 12.30 and is included in your registration.

    Session topics include:

    • Future of Pharmaceutical Quality and the Path to Get There – Using a Six Sigma Capable Process
    • Management of Residual Uncertainty in the Regulation of Biological Products
    • Statistical Considerations for Blend Uniformity/Content Uniformity Acceptance Criteria
    • PV Strategies and Considerations for Continuous Manufacturing
    • Interactive Regulatory Panel Discussion

Social Media

Follow the official hashtag of the ISPE 2016 Process Validation and Process Validation Statistics Conferences #ISPEPV and use it in your social media communications throughout the event to stay up-to-date on what is going on at the conferences and share your experiences.

  • Follow ISPE on Twitter @ISPEorg to see what’s trending daily at the Process Validation Conference
  • Don’t forget to like the official ISPE Facebook page to see what conference attendees are sharing

Attendee Roster

Who’s attending?  View the list of attendees who will be at the 2016 Process Validation and Process Validation Statistics Conferences.

Make plans now to meet up with them at one of the many networking events.


Accessing Presentations

In order to remain committed to reducing ISPE’s carbon footprint, printed handouts will not be available on site. Final presentations received from speakers who have agreed to make them available are accessible on the conference website. Additional and updated presentations will be added on an ongoing basis through 10 November.


Give Us Your Feedback

We welcome your feedback throughout the year on ISPE’s continuing education events. The conference survey will be emailed to all attendees at the close of the conference. Thank you for providing your feedback and ideas for future topics.

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