Two-day Seminar on Disposables at ISPE Conference
Wednesday, January 23rd, 2008
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Archive for January, 2008
Attend a Two-day ISPE Seminar on Lyophilization
Wednesday, January 23rd, 2008On 27-28 February 2008, The Lyophilization: Meeting the Challenges of a Critical Technology seminar at the 2008 ISPE Manufacturing Excellence Conference
addresses how the exceptional product attributes of a lyophilized product need to be balanced with challenges that may limit use of this technology including complex formulation and lyophilization cycle development, as well as high cost and complexity of equipment. Attendance recommended for design, development, operations, maintenance and compliance professionals involved in lyophilization of drug products. Communities of Practice (COPs): Biotechnology, Process/Product Development, and Sterile Products ProcessingSession leaders: Miquel Galan, Director of Innovation and Research and Development, IMA - TEL STAR, S.L., Spain, and Reuben Zielinski, Senior Director Operations, Catalent Pharma Solutions Learn More/Register On-line Today
ISPE Appoints John Berridge, PhD, as European Regulatory Affairs Advisor
Wednesday, January 23rd, 2008ISPE has appointed John Berridge, PhD, as Europe Regulatory Affairs Advisor. He will take the post 1 February 2008. In this position Berridge will assist ISPE in its interactions with European regulatory authorities as well as helping to move forward ISPE’s new Product Quality Lifecycle Implementation (PQLI) initiative. ISPE, which has Members from 90 countries, provides a neutral forum for industry, regulatory agencies, academics and individuals to exchange practical experience, collaborate and communicate.
“Along with Joe Phillips, our International Regulatory Affairs Advisor, and
Bob Tribe, Asia Pacific Regulatory Affairs Advisor, John now completes a team that is second to none,” saidBob Best, President and CEO of ISPE. “We are truly blessed with this lineup of regulatory affairs specialists.” Tribe joined ISPE from the Therapeutic Goods Administration (TGA) inAustralia, where he served as Chief GMP Auditor for 23 years. Phillips spent 44 years with the US Food and Drug Administration, rounding out his career as Deputy Regional Director of the Agency’s Central Region.
Berridge retired from Pfizer Global Research and Development at Sandwich, England at the end of January 2006 as European Vice President of Pharmaceutical Sciences. Since then he has been a consultant and advisor to a portfolio of international clients, and a leader and visionary in ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative, which was launched in 2007. PQLI brings together industry and regulators in the United States,
Europe, and Asia-Pacific to help industry find solutions to the challenges in implementing ICH guidances. “ISPE’s PQLI provides the linkage between the high level ICH guidelines and the needs of those wanting to implement them. These sessions are critically important opportunities to understand the latest developments from those directly involved in ICH and to contribute to clarifying the issues and opportunities of implementation,” according to Berridge.Berridge spent more than 31 years at Pfizer, starting as an analytical chemist, and more recently responsible for all aspects of chemistry, pharmacy, analytical, and regulatory CMC inEurope. His research interests have been directed toward high-performance liquid chromatography, with special emphasis on the use of chemometrics to aid method development. More than 40 papers and a book have been published and this research has been recognized by the award of the Chromatographic Society’s Jubilee medal in 1989. Berridge was involved in the ICH processes from their inception, representing EFPIA in the quality topics discussions. He has contributed to guidelines on impurities in drug substances and their dosage forms, specifications, was the industry rapporteur for the Common Technical Document (Quality) and was the rapporteur for the Pharmaceutical Development Guideline (Q8 and its addendum which reached Step 2 in November of this year). At FIP’s 55th World Congress in Stockholm in 1995 he was presented with an IPS award for his outstanding contribution to industrial pharmacy, and in September 1997 he was awarded the Royal Pharmaceutical Society Chiroscience award for his services to the pharmaceutical industry and for his work within ICH.
ISPE to Hold Student Leadership Forums
Wednesday, January 23rd, 2008The ISPE International Student Development Committee will hold four free Student Leadership Forums in 2008, designed to promote the exchange of information, ideas, and lessons learned among students, industry and faculty; teach/review students’ networking skills; review résumés; and create engagement among attendees.
Southeast SLF will be hosted by the ISPE Carolina-South Atlantic ChapterSaturday, 9 February - North Carolina State University, Raleigh, North Carolina, USA
West Coast SLF - Hosted by the ISPE San Francisco/Bay Area ChapterSaturday, 9 February, Embassy Suites Walnut Creek, Walnut Creek, California, USA
Northeast SLF will be hosted by theISPEDelawareValley Chapter, Saturday, 29 March (immediately following INTERPHEX Philadelphia), Union League ofPhiladelphiaPhiladelphia, Pennsylvania, USA
Puerto Rico SLF will be hosted by the ISPE Puerto Rico Chapter on Saturday, 26 April at the Interamerican University at Bayamon in San Juan, Puerto Rico, USA.
To register on-line: http://www.ispe.org/cs/root/student_resources/2008_student_leadership_forums
The organizers of the Forums are seeking more volunteers to serve as mentors to students! If you would be willing to spend one day talking about the pharmaceutical industry profession and your own career path with students, please contact Tracey Ryan, tryan@ispe.org.
ISPE Webinars — Only $99 for ISPE Members
Wednesday, January 23rd, 2008Get industry know-how 24/7 from the convenience of a computer with Internet access. ISPE Web-based education provides the knowledge, skills, and best practices you need for job success today and into the future. Visit www.ISPE.org/webinars to select programs that match your interests. Webinar registration is only $99 for ISPE Members. E-mail ispe_webinars@ispe.org with specific questions.
Live Webinars - Real time, interactive sessions on industry topics you need to know about today. Hear directly from the experts, and submit questions via keyboard or voice input. Registration includes participation in the live Webinar day of event, and access to the recorded version for 15 days thereafter. Cost for One (1) Webinar Login: Member $99, Nonmember $150.Upcoming Live Webinars - IP Series
Overcoming Regulatory and Logistical Hurdles When Conducting Clinical Trials in India, 23 January 2008, 11.00 EST
Speaker: Barbara H. Ost, Vice President, Quality Assurance & Compliance, Bilcare, Inc.
Good Training Practices! Improving Compliance and Performance with Effective Training, 12 February 2008, 11.00 EST
Speaker: Kristina Spitler, Training Manager, Almac Clinical Services
Recorded Webinars - These programs offer basic to intermediate knowledge on topics such as: product development, facilities and equipment, information systems, supply chain management, production systems, regulatory compliance, and quality systems. Many programs serve as an excellent primer prior to attending ISPE classroom training or conference seminars. Registration offers access to the recorded Webinar for 15 days. Cost for One (1) Webinar Login: Member $99, Nonmember $150.
ISPE Downloads @ iTunes — www.ISPE.mypodcast.com
Introduction to GAMP®5 - New!
Risk MaPP Baseline® Guide, Introduction and Update - Complimentary, New!
CPIPSM Credential Overview
An Introduction to ISPE
And more …
