Jenn Walsh, Associate Director Manufacturing Technology, Bristol Myers Squibb moderated a night session on process validation.

Dafni Bika, PhD, VP, Global Manufacturing and Supply, Bristol Myers Squibb, discussed the implementation status of the lifecycle validation paradigm. She asked delegates “What is process robustness?” “Robustness”, she said, is a strategic initiative and a natural extension of Quality by Design (QbD)” She went on to clarify that when we talk about “in control” adding that what we mean is “in statistical control.”

Karthik Iyer, Senior Policy Analyst, CDER/OC/OMPQ, FDA, presented a regulatory update on the new paradigm in validation, including recently issued warning letters and 483 observations.

Following the informative  and rather provoking discussion, a panel including Alex Vichmann, Operations Research Analyst, CDER/OPS/SRS, FDA; Rick Friedman, Associate Director, Office of Manufacturing and Product Quality, FDA/CDER/OMPQ; and  Joanne Barrick, RPh, Advisor, Global Validation, Eli Lilly& Co. answered a variety of in-depth and thoughtful questions from the audience. Questions ranged from topics regarding data mining, raw material variability, process robustness, and the point at which you can stop manufacturing.  The Q&A continued with process monitoring, testing differences between data flow of biologics, oral solid dosage forms, and the status of dialogue with other health authorities.