From the Experts: Quality Manufacturing Regulatory & Technical Update

QMan18 Conference

In addition to strong Regulatory participation (FDA and international) in keynote and track break-out sessions, the planning committee for the 2018 ISPE Quality Manufacturing Conference is putting together some of the best technical quality manufacturing content led by industrial visionaries and experts. For example:

  • A session focused on accelerated development and exploring both the industries and regulatory experience with these programs that have significant reduced timeliness and demands.
    • What are the challenges that industry and/or regulators experience?
    • What are some of the important lessons learned that can help shape future improvements?
  • Process validation for continuous manufacturing session which will explore Continuous Process Verification and how that might help/ benefit Continuous Manufacturing. In addition, there will be a workshop on Continuous Manufacturing starting right after this conference, so what a great opportunity to bridge these activities.
  • Technology transfer session will discuss the impact of market trends, the common obstacles and importance of five key areas of the technology transfer lifecycle, and how to incorporate these five key areas into a technical transfer plan for greater flexibility, shorter on-time delivery and a successful outcome. With today’s ever so complex supply chains, this is critical to assure supply and quality of important medications.
  • Patient centric specifications (clinically relevant specification) plenary session will feature the ISPE team that has been developing thoughts of what this means for various disciplines (API, Impurities, Dissolution, and Biologics). We will also hear from a veteran FDA expert who will share the FDA perspective on the recent guidance.

I encourage you to visit our web page as we begin to update it with details of the education sessions and themes (Regulatory, Quality Manufacturing, and Facilities and Equipment). The conference is shaping up to be one of the highlights of the year. I hope to see you all there.

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Timothy Watson Photograph

Chair: Timothy Watson, PhD
Research Fellow/CMC Advisory Office
Pfizer, Inc.

The ISPE Quality Manufacturing Conference is the foremost pharmaceutical quality event of the year. It provides a unique forum for attendees and speakers from industry, academia, and regulatory to address areas for opportunities to assure innovation and continuous supply of high-quality products to our patients.