On March 31, 2014, experienced statisticians from 50 companies and 9 countries, assembled for the sold-out 2014 Lifecycle Approach to Process Validation/ Statistician Forum. ISPE would like to thank everyone who attended the two-day conference held at the Westin Hotel Philadelphia for making the event a resounding success.

With robust content in all presentations, including keynote presentations from FDA leaders, round-table discussions and many notable moments that listing them all would be impossible. A few highlights include:

  • Grace McNally, Senior Policy Advisor, FDA/CDER/OC, offered a keynote presentation on The Status of Implementation of the Lifecycle Approach to Process Validation focusing on the FDA’s perspective of the progress companies are making toward implementation.
  • Breakout sessions covered a wide variety of topics relating to solutions for statistical implementation challenges of the lifecycle approach to Process Validation.  Speakers presented information from Stages 1, 2, and 3 to ongoing Process monitoring.
  • One of the liveliest discussions, facilitated by FDA’s Alex Viehmann, revolved around determining the number of PPQ batches necessary for validation.
  • Karthik Iyer, Senior Policy Analyst, FDA/CDER/OC/OMPT/OMPQ, discussed the benefits of opening the dialogue between industry and the agency to achieve consistency in expectations and outcomes.

This conference was the first of its kind in the industry.  With 92% of delegates urging ISPE to repeat the Forum again in 2015. Mark your calendars, information on the 2015 ISPE Statistician Forum will be coming soon.