“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 have their participation in our upcoming event in Washington, D.C.”
Speaker information ? along with seminar agendas and training course outlines ? for the four-day event have been posted to the ISPE Web site and include the following listings:
o Richard Friedman (Director, Mfg. & Product Quality, CDER), Tara Gooen (Chemical Engineer, CDER), Robert Sausville (Supervisory Consumer Safety Officer, CBER), and Joyce Rockwell (Consumer Safety Officer, CBER) will be featured US FDA speakers at the 18th Annual Barrier Isolation Technology Forum: Innovation Updates and New Case Studies.
o Helen Winkle (Director, Office of Pharmacy, CDER), Christine Moore (Deputy Director, CDER), and Sharmista Chatterjee (Staff Fellow/Reviewer, CDER) will be featured US FDA speakers at the PQLI: Science, Regulatory, Manufacturing, and Engineering Working Together for Global Realization and Implementation of the ICH Quality Vision seminar. Joseph Famulare (Deputy Director, Office of Compliance, CDER), Richard Friedman (Director, Mfg. & Product Quality, CDER), Vibhakar Shah (Consumer Safety Officer, CDER), Elaine Morefield (Supervisory Chemist, CDER), Grace McNally (Senior Compliance Officer, CDER) and Patrick Swann (Deputy Director, Division of Monoclonal Antibody, CDER) of the US FDA have been invited, as well.
o Ilisa Bernstein (Sr. Advisor Pharmacist, CDER) and Steven Silverman (Regulatory Counsel, CDER) will be featured US FDA speakers at the Global Supply Chain Integrity and Anti-counterfeiting seminar. A representative from the FDA’s Office of Policy and Program Planning, CDER has also been invited to speak.
o Barry Rothman, Consumer Safety Officer for the FDA’s Division of Manufacturing and Product Quality, CDER has been invited to speak at the Current and Future Packaging Challenges for Investigational Products seminar.
o H. Gregg Claycamp, PhD, the Associate Director of Risk Analysis & Strategic Policy Assessment, CVM will be the featured FDA speaker at the Applied Risk Management – Addressing Cross Industry Challenges seminar.
o Malcolm Oliver, GMP Inspector for the MHRA, has been invited to speak at the Commissioning and Qualification (C&Q): Practical Applications of Science and Risk-based Approaches to Validation seminar, along with several confirmed leaders of the pharmaceutical manufacturing industry.
o As an additional resource on the topic of C&Q, there will be a live Webinar 5 May 2009 on Implementing the ASTM Standard for Verification (C&Q).
In addition, there will be seminars devoted to GAMP and facility renovation, as well as two-day training courses. They are:
o GAMP Good Practice Guides: Validation of Process Control Systems (VPCS), and Calibration Management, A Risk-Based Approach
o Extreme Facility Makeover: Successful Path to Facility Renovation and Retrofit
o Training - Basic Principles of Computerized Systems Compliance
o Training - Applying the GMPs
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.
For complete seminar information, and to register for the conference, visit www.ISPE.org/washingtonconference, or call ISPE Members Services at tel: +1-813-960-2105. For press passes to attend this event, contact Marni Schribman, ISPE Communications Manager, by tel: +1-813-960-2105, fax: 1-813-264-2816, or e-mail: mschribman@ispe.org.
About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 25,000 pharmaceutical science and manufacturing professionals in 90 countries. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; its Asia Pacific office in Singapore; and its newly established office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.
