iSpeak Blog

Solutions-Based Education to Improve Your Processes at the 2015 Quality Manufacturing Conference



With the ISPE/FDA/PQRI Quality Manufacturing Conference fast approaching, the conference program committee invites you to join them on 1 – 3 June 2015 in Washington, DC, for three days of solution-based education and networking. The 2015 ISPE/FDA/PQRI Quality Manufacturing Conference, formerly known as the ISPE/FDA CGMP Conference, will bring together the pharmaceutical industry and FDA for three days of open dialogue across the spectrum of modernization in manufacturing, regulatory insights and quality systems – and continue the critical discussions started in April at the ISPE Quality Metrics Summit. And, that is exactly why it’s listed in the Federal Registry and the FDA and PQRI have committed to co-sponsor this event with ISPE, your trusted source for pharmaceutical knowledge. Attending this conference presents a great value and an excellent opportunity to meet other industry experts and learn more about cutting edge technologies from more than 40 exhibiting companies that can improve your processes and bottom line. Take into consideration these featured sessions.

  • Adapting Legacy Facilities to Improve Biomanufacturing
  • Quality Metrics – An Update from the ISPE Quality Metrics Summit
  • Breakthrough Therapy – CMC and Quality System Considerations
  • Process Capability with a View on Biotech Processes
  • Quality Risk Management for CMC Submissions
  • Continuous Manufacturing
  • Drug Shortage Prevention and ISPE's Gap Analysis Tool
  • Adapting Legacy Facilities for Continuous Supply
  • Contamination Control, Biotechnology Production and Aseptic Process Facilities
  • Lifecycle Data Integrity
  • Operational Excellence
  • Q7, Q11 and Q12
  • FDA View on Track and Trace

In addition, keynote speakers Janet Woodcock, MD, Director, CDER, FDA, Juan Andres, Head of Technical Operations, Novartis AG, and Andrew Skibo, Regional VP, Supply Biologics, Global Engineering and Real Estate, MedImmune/AstraZeneca are slated to present FDA Perspectives, Promoting Quality with Innovative Manufacturing and Supply Chain Risk Management, respectively. After returning from the conference, you will be able to immediately apply your new found knowledge to help assure your operation remains competitive in our continued challenging industry environment. ISPE and the program committee look forward to seeing you there. For more information about the conference or to register, please visit