21 CFR Part 11 Course to be Offered at ISPE 2010 Philadelphia Training Event

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Danielle Hould
ISPE Communications Manager
Tel: +1-813-960-2105, ext. 277
Fax: +1 813.264.2816

21 CFR Part 11 Course to be Offered at
ISPE 2010 Philadelphia Training Event
Course Features Up-to-the-Minute Content on the Status of the
USFDA’s Current Re-examination

(TAMPA, FLORIDA, USA, 26 October 2010)ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, announced today that it will offer seven training courses, including a session focused on complying with 21 CFR Part 11, at its 2010 ISPE Philadelphia Classroom Training. The event will take place 6-9 December 2010 at the Hilton Philadelphia Airport in Philadelphia, Pennsylvania, USA.

As a Member-based organization, ISPE draws from the expertise of its Members to develop training courses that address industry demands and to provide in-depth knowledge on a specific topic. Many courses utilize case studies, team exercises and ISPE Guidance documents to immediately apply the learning objectives to real-life situations within their own organizations.

One of the event highlights will be the intermediate-level course, “Complying with Part 11 – Risk Management: Applying the GAMP® Good Practice Guide: Electronic Records and Signatures Principles.” Led by Sion Wyn, acknowledged computer systems validation expert and member of the USFDA’s re-examination team, the course will feature up-to-the-minute information about the FDA’s current re-examination of the 21 CFR Part 11 and the European regulatory expectations as reflected in the draft revised Annex 11. Participants will learn how to implement a risk management approach to ensure compliance of regulated electronic records and signatures through application of appropriate controls.

Other courses will focus on sustainability within HVAC, including HEPA filter theory; regulatory philosophy in Sterile Drug Manufacturing facilities; and differentiating between regulatory requirements and regulatory myths relative to Pharmaceutical Water Distribution and Storage Systems. Additional courses include Practical Application of GAMP5 and Oral Solid Dosage Forms. ISPE partnered with the ISPE Delaware Valley Chapter to select the courses for 2010 Philadelphia Classroom Training.

In addition to Wyn, recognized industry experts Dave DiProspero, Gary V. Zoccolante, Norman Goldschmidt, and Diana Knittel-Pace will be on-hand to share their knowledge and experience as they lead the training discussions.

Some courses will offer CEUs with content related to the Certified Pharmaceutical Industry Professional™ (CPIP™) technical knowledge and competency elements.

Full course descriptions, instructor bios, and registration information can be found at www.ispe.org/2010PhiladelphiaTraining ( 233 KB).

About ISPE

ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 24,000 technical professionals working in or serving the manufacturing sector or drug development in the pharmaceutical industry in 90 countries. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop their technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.


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