iSpeak Blog

Implementation of the Lifecycle Approach to Process Validation Statistics

Maneesha Altekar, PhD
ISPE 2016 Process Validation Statistics Conference


The ISPE 2016 Process Validation Statistics Conference is in its 3rd year, continuing with its successful tradition of bringing together pharmaceutical leaders within the industry and regulatory authorities to share their thoughts in the implementation of the lifecycle approach to process validation. The keynote talks are always inspiring – and this year is no exception:

The ISPE 2016 Process Validation Statistics Conference will feature:

  • Advances in statistical applications to process validation Stages 1-3 along with applications and case studies
  • Introducing attendees to newer concepts in process validation such as applications to Packaging and Continuous Manufacturing
  • Panel discussions at each session, which will allow for a more interactive opportunity for you to engage with the speakers and each other
  • Polling throughout the meeting that will provide invaluable benchmarking information for you and your organization
  • Networking breaks allowing for an opportunity to catch up with old colleagues and make new contacts

As always, there will be a mixed group of statisticians and process validation practitioners, representing every category of pharmaceutical manufacturing (small molecule, large molecule, devices, and more). For those of you who are not statisticians but want to know more about the statistics used in process validation and be better prepared for the conference sessions?  There will be two 90-minute session on the first day of the conference to make you become better acquainted with some of the key topics that will be discussed during the sessions:

Learn more and register for the ISPE 2016 Process Validation Statistics Conference to be held on 25 – 27 October in Bethesda, MD USA, and bring your colleagues with you!