ISPE, a global not-for-profit association of 25,000 pharmaceutical science and manufacturing professionals, announced today that it will present several industry-impacting sessions this year at its Washington Conference 2-5 June 2008 at the Crystal Gateway Marriott in Alexandria, Virginia, USA.

“ISPE’s Engineering Regulatory Compliance Conference in Washington, D.C. is truly a practical engineering forum,” said Grace Chin, Senior Vice President of Science and Technology for SNC-Lavalin and a member of ISPE’s Washington Conference Task Team. “The event will provide industry professionals with direct access to regulators who are focused on the real issues we face daily.”

One of the highlights of the event will include a multi-day, multi-track program co-sponsored by the US Food and Drug Administration (FDA) and ISPE entitled, Regulatory Perspectives on Hot Topics, Regulatory Trends, and Observations on 4-5 June. These highly interactive sessions provide a forum for exchanging ideas, as well as an opportunity to hear about new initiatives and interface with dozens of regulators.

The ISPE Facilities Summit 2008: Innovation and Ultra Fast Delivery, 2-3 June, presents an intensive forum where top thinkers and service practitioners discuss project delivery, regulatory, and manufacturing technology/operations. Of particular importance to project managers, this session offers Lessons Learned from two of the Facility of the Year 2008 Category Winners and a summary of insights gleaned from all of the submissions. Interactive breakout sessions provide attendees an opportunity to discuss possible ideas and solutions – capturing the best ideas from presenters and delegates alike.

The RiskMaPP and Applying ICH Q9 Principles Containment seminar addresses the risk of cross-contamination and provides a critical, unique opportunity for attendees to provide input to the EMEA as they conduct their toxicology studies for dedicated facilities. Persons interested in handling beta-lactams will want to attend the Containment Technologies Forum: Concepts, Case Studies, and Compliance seminar. Cleaning for the 21^st Century: Science and Risk-based Approaches rounds out the Containment offerings.

Other important sessions during the four-day conference include:

• 17th Annual Barrier Isolation Technology Forum: Innovation Updates and New Case Studies
• Critical Utilities: Pharmaceutical Water and Gas Systems
• Science and Risk-based Approach for C&Q: Application of the New Guide, Installation and Verification (In Support of ASTM E2500)
• GAMP^®5 Enabling Innovation and Technological Advance – One-day Quick Start – The Best Presentations from the GAMP^®5 Launch
• Designing and Validating Manufacturing Execution Systems

For more information or to register for the Washington Conference, please visit www.ISPE.org/washingtonconference.

Share This

ISPE mourns the loss of our close friend and senior Society advisor, Joseph X. Phillips, who passed away on 13 April. Phillips was 73 years old.

Through his dedicated service to ISPE, including his most recent role as International Regulatory Affairs Advisor, Phillips was pivotal in leading ISPE in its global initiatives and worked tirelessly behind the scenes to facilitate key relationships with regulators and industry leaders around the world. His vast and valuable contributions to ISPE will benefit Members and industry for many years to come.

Phillips had a distinguished career with the US Food and Drug Administration for 44 years. He ended his career in the position of Deputy Regional Director of the Agency’s Central Region. He was heavily involved in training of FDA Investigators and in planning and managing pharmaceutical programs including the Pre-Approval Inspection program and the SUPAC (Scale-Up and Post Approval Changes) for field operations. Phillips was a principal negotiator for the US/EU Mutual Recognition Agreement and was the FDA Lead to the International Conference on Harmonization (ICH) Expert Working Group for GMP Guidance for Active Pharmaceutical Ingredients (ICH Q7A).

Phillips joined ISPE in 2003 as Regulatory Affairs Advisor, the same year he was appointed as a special government employee to the FDA’s Pharmaceutical Science Advisory Committee that is involved in the agency’s “Risk-Based Approach to Pharmaceutical cGMPs for the 21st Century” initiative. Phillips was a founding member of ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative and was a strategic advisor to Society President/CEO Bob Best.

“I have long subscribed to the theory that no one is irreplaceable,” said ISPE President Bob Best. “Joe Phillips is an exception to that rule. I have never met a nicer, kinder human being than Joe Phillips. He was truly loved by people all over the world. And the list of his contributions, both as a long-time representative of the FDA, and later for ISPE, is enormous. This was truly a “great” man in every sense of that word.”

Phillips is survived by his wife, Dolores, and sons Joe and John. Joe Jr. followed in his father’s footsteps and works for GlaxoSmithKline.

Share This