What Are You Waiting For? A Special Invitation? Well Here It Is!

      I would like to personally invite you to attend the 2017 ISPE/FDA/PQRI Quality Manufacturing Conference, jointly sponsored by and organized with the FDA. If you have been to one of the previous Quality Manufacturing Conferences, you have an idea of the value of this opportunity. If you have never been to this conference before you will immediately see how important and relevant this is to your area of expertise in the manufacturing life cycle. This year promises to meet and exceed your expectations by emphasizing the top priorities from CDERs Office of Pharmaceutical Quality (OPQ) and Office of Compliance and the Office of Global Regulatory Policy and Operations. Highlights of the conference include:

Top speakers from the FDA and pharmaceutical industry, including:

• Four interactive workshops, with FDA and pharmaceutical industry facilitators, on CDER Office of Pharmaceutical Quality priorities including:
  • Linking Quality to Clinical Relevance
  • Modernizing Pharmaceutical Manufacturing through Emerging Technology and Innovation
  • Designing Proactive Approaches to Facility and Life Cycle Quality Management
  • Implementing Next Steps for Quality Metrics
• FDA Keynote Session Following up on last year’s presentation by Dara Corrigan, Acting Deputy Commissioner, Office of Global Regulations and Policy, which referenced FDA’s efforts on Mutual Reliance, Helen Y. Saccone, PharmD, CDR, Associate Director, Global Regulatory Policy, FDA/OC/OGROP will provide an update and implementation plans for the EU USA MRA agreement signed earlier this year. You absolutely will not want to miss this! She will be followed by Thomas Cosgrove, JD, Director,Office of Manufacturing Quality, with an update on important compliance trends and initiatives.

And that is just the tip of the iceberg!  Additional highlights include:

• Drug Shortage Prevention
• Data Integrity
• Emerging Therapeutic Entities
• Woman in Pharma

Calling all Young Professionals, Senior Leaders, Development, Quality, Engineering, Facility, and Manufacturing Professionals, and everyone involved in the life cycle of manufacturing medicines for patient needs today and in the future, you need to attend! I hope to see you there!

P.S. Don’t miss the Data Integrity Workshop on June 4^th, immediately before the 2017 ISPE/FDA/PQLI Quality Manufacturing Conference, with FDA Compliance, Pharmaceutical Industry Compliance and ISPE GAMP® experts, facilitating an interactive workshop on successfully implementing a robust data integrity program avoiding compliance issues. Sign up now:  www.ISPE.org/2017-Data-Integrity-Workshop/Register