Session 5: Manufacturing Investigations- Fix it Now or Fix it Later
4:00 PM – 4:45 PM | East Red Level, Suite 10
Manufacturing Investigations- Fix it Now or Fix it Later
Dr. Blackwell will describe some of the most impactful investigations he has been involved with, including one that may be the most important manufacturing investigation economically in the history of the industry. This will be followed by lessons learned, including: 1) why it’s important to get to true root cause as quickly as possible; 2) elements of a highly effective investigation quality system; and 3) what the FDA is looking for when reviewing an investigation (common mistakes). Audience will be encouraged to tell “war stories” and ask questions for the last 10 minutes. Three takeaways: 1) Why it’s important to get to true root cause as quickly as possible. 2) Key elements of a highly effective investigation quality system. 3) Common mistakes and what the FDA looks for in reviewing investigations.
Speaker:
James Blackwell, President, Windshire Group, LLC
Sponsored by:
Biography:
Dr. James Blackwell is one of the industries’ top experts. As Founder and a Principal Clients range from virtual start-ups to world class multinationals. As Founder and a Principal Consultant for the Windshire Group, LLC, and Labshire, LLC. Dr. Blackwell has been a leading consultant for almost two decades in the areas of CMC, process development, quality, laboratories, and manufacturing for all major therapeutic classes, from pre-IND through commercial operations. He has been involved with a consent decree and third-party monitoring, quality system remediation, and quality mentoring for several multinational corporations. Dr. Blackwell has held senior technical positions for leading companies and was head of site technical operations for the launch of Humira™. He has been on the founding management team of several start-ups. Dr. Blackwell’s accomplishments include working on some of the industry’s most innovative and important therapies and providing due diligence expertise for more than forty investment opportunities. James is a member of ISPE, PDA, AAPS, ISCT, and RAPS. He holds degrees in chemical engineering (Ph.D.), microbiology (M.S.), and dual business/technology management (M.B.A./M.S.).
