Signature ISPE Conference Seeks to Shape Dialogue on Industry-Critical Quality Manufacturing Initiatives

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ISPE announced its fifth annual ISPE/FDA/PQRI Quality Manufacturing Conference, taking place 5 – 7 June in Arlington, Virginia USA. This signature event features a series of concurrent workshops designed to facilitate open dialogue between pharmaceutical industry and regulators to achieve greater alignment on critical quality issues.

“This conference provides the unique opportunity for face-to-face dialogue with regulatory and industry experts in each of the four core workshops,” said John Bournas, ISPE CEO and President. “Attendees can bring their organizations’ quality manufacturing concerns to the table for discussion and help to shape the ongoing dialogue around key industry priorities and best practices.”

A team of pharmaceutical industry and regulatory experts created this year’s program around industry-critical quality initiatives, specifically the 2017 priorities of the FDA Office of Pharmaceutical Quality. Attendees will have the opportunity to hear from key thought leaders throughout the conference on manufacturing quality, compliance, and regulatory global harmonization.

Keynote speakers include:

  • Michael Kopcha, PhD, RPh, Director, Office of Pharmaceutical Quality, FDA
  • François Sallans, PharmD, Vice President, Quality & Compliance, Chief Quality Officer, Johnson & Johnson
  • Roger Nosal, PhD, Vice President & Head of Global Chemistry, Manufacturing & Controls, Pfizer Inc.
  • Thomas Cosgrove, JD, Director, Office of Manufacturing Quality, FDA/CDER/OC

In addition to keynote and featured presentations, interactive workshops will dominate the conference format, focusing on each one of the 2017 priorities of the FDA Office of Pharmaceutical Quality:

  • 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

In conjunction with the ISPE/FDA/PQRI Quality Manufacturing Conference, ISPE will be hosting its second annual Data Integrity Workshop on Sunday, 4 June. The half day workshop includes an overview of the topic, a discussion panel, and two sets of three concurrent sessions, providing a unique opportunity for attendees to gain a practical understanding of current data integrity issues and the knowledge necessary to begin to address potential challenges.

Discover the key objectives that will be discussed during the workshop sessions at the ISPE/FDA/PQRI Quality Manufacturing Conference.  In addition, learn more about the 2017 ISPE/FDA/PQRI Quality Manufacturing Conference and Data Integrity Workshop by visiting the official event websites. 

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