ISPE, a global not-for-profit association of 24,000 pharmaceutical science and manufacturing professionals, and the US Food and Drug Administration (FDA) are co-sponsoring US FDA-ISPE Collaboration: Pharmaceutical Quality Systems, a highly-interactive two-day session 9-10 June at its 2010 Washington Conference – Applying Risk-based Approaches, to be held at JW Marriott in Washington on 7 to 10 June 2010.
As part of US FDA’s Pharmaceutical cGMP for the 21st Century Initiative, the US FDA, along with industry leaders and regulatory agencies from other countries, have identified key components of a modern pharmaceutical quality system in ICH Q10. Co-sponsored by the US FDA, this two-day seminar will provide a special Town Hall forum for the exchange of information between the US FDA and the industry and will focus on pharmaceutical quality systems and the implementation of elements that enhance its effectiveness.
“Regulators from around the world have always been very generous in sharing their knowledge and expertise with ISPE Members and our conference attendees,” said ISPE President and CEO Robert P Best. “We are very privileged to again have their participation in our upcoming event in Washington.”
The ISPE 2010 Washington Conference brings together all levels of pharmaceutical industry professionals to network and benefit from a variety of seminars and trainings. Washington Conference features include Barrier, PQLI/QbD, C&Q, Critical Utilities, Process Validation, Cleaning, Biotechnology, GAMP Guides: Operation of GxP Systems GPG and MES GPG, Sustainability, Biologics Manufacturing, and HVAC.
Several ISPE Guidance documents will be launched or discussed at Washington Conference including GAMP Good Practice Guide: Manufacturing Execution Systems, GAMP Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems, and ISPE’s HVAC Good Practice Guide. A MedImmune plant tour of their Therapeutic Protein facility is also featured as part of the Trends in Biologics Manufacturing session.
Speaker information, along with seminar agendas and training course outlines for the four-day event has been posted to the ISPE Web site and include the following:
In addition, the event will include tabletop exhibits from more than 60 of the industry’s top suppliers of pharmaceutical manufacturing equipment, and networking opportunities for pharmaceutical industry professionals. ISPE’s Career Solutions Center will also be featured at the event.