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.
Bethesda, Maryland USA (PRWEB) March 30, 2017
The International Society for Pharmaceutical Engineering (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 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 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.
To learn more about these events, visit http://www.ISPE.org/2017-Quality-Manufacturing-Conference and http://www.ISPE.org/2017-Data-Integrity-Workshop.
The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical life cycle. The more than 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland, USA, and an operations and training center in Tampa, Florida, USA. Visit http://www.ISPE.org for more information.
For more information, contact:
Senior Director, Marketing Communications
International Society for Pharmaceutical Engineering (ISPE)