ISPE has introduced three new product lines to its extensive Online Learning library: the ISPE 2009 Washington Conference Session series, the Certified Pharmaceutical Industry Professional (CPIP) Online Course series, and the Good Manufacturing Practices (GMP) Online Training Course series.
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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 21st Century: Science and Risk-based Approaches rounds out the Containment offerings.
Other important sessions during the four-day conference include:
For more information or to register for the Washington Conference, please visit www.ISPE.org/washingtonconference.
ISPE, a global not-for-profit association of 25,000 pharmaceutical science and manufacturing professionals, is partnering with a major American university for the first time to provide comprehensive, hands-on biotechnology training 12-14 May at North Carolina State University’s Golden LEAF Biomanufacturing Training and Education Center (BTEC) in Raleigh, North Carolina, USA.
“ISPE is proud to be a part of this innovative partnership with North Carolina State University to bring a unique training experience to pharmaceutical professionals,” said Bruce Davis, Chairman of ISPE’s International Board of Directors.
The training program will offer four three-day courses that include lectures, problem-solving workshops, and hands-on activities at BTEC’s state-of-the-art cGMP pilot plant facility. Participants will learn how to implement new concepts, improve process efficiency, address manufacturing challenges, and much more.
The BTEC facility simulates a biomanufacturing pilot plant capable of producing biopharmaceutical products and packaging them in a sterile environment using commercial-scale equipment. It is currently the only facility in the U.S. that can do this from inoculation to filling, and the partnership between ISPE and North Carolina State University is one of the few opportunities for professionals to receive this hands-on, industry-specific training.
Developed for professionals in the pharmaceutical manufacturing and biotechnology industries to help increase knowledge in their respective fields, the training will focus on current issues, including:
• Process Validation for Biotechnology Manufacturing
• Biopharmaceutical Manufacturing Facilities
• Getting the Most from Your Bioreactor
• Disposables in Biomanufacturing: An Objective Assessment
Recognized industry experts will present relevant curriculum to give professionals the tools they need to be successful in their careers while earning Continuing Education credits. In addition, several of the courses contain information related to competencies for the Certified Pharmaceutical Industry Professional SM (CPIPSM).
For more information on specific courses and instructors, please visit www.ISPE.org/BTECtraining.
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On 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
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