Biotechnology and GMP Courses to be Featured at San Francisco ISPE Professional Development Training

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 sessions focusing on biotechnology and Good Manufacturing Practices (GMP) at its San Francisco Professional Development Training event to be held 7 - 10 March 2011 at the Hotel Monaco San Francisco in San Francisco, California, USA. This marks the first time the ISPE training event has returned to the San Francisco area since 2007.

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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, “An Overview of Biopharmaceutical Manufacturing Processes,” led by top biotechnology consultant and industry expert Mark Witcher, PhD. The course will survey commonly used biopharmaceutical manufacturing practices, including cell culture and fermentation, harvest and recovery, viral removal and inactivation, and purification processes. The increased use of biopharmaceutical manufacturing processes makes this course highly recommended for individuals responsible for process design, process validation, and equipment design and selection for biopharmaceutical applications. Management, supervisory, and engineering personnel beginning work in biopharmaceutical product development, production operations, quality assurance and regulatory compliance are also encouraged to attend, as is anyone with an interest in learning how biopharmaceutical manufacturing processes work.

The course, “Q7A: Implementing Good Manufacturing Processes” is expected to be another top draw of the Professional Development Training event. Led by engineering design expert Jeffery Odum of NCBioSource USA, the course focuses on the compliance issues unique to biotechnology and pharmaceutical companies that manufacture active pharmaceutical ingredients (API). The course will review and interpret the key GMP requirements specific to bulk biopharmaceuticals and familiarize participants with the USFDA's interpretation of ICH Q7 as defined in the Q7A, the Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. Professionals in quality assurance, quality control, development and manufacturing, facilities engineering and maintenance, manufacturing equipment and systems design and production, and regulatory roles related to the production of API are encouraged to attend.

In addition to these courses, the San Francisco Professional Development Training event will feature courses on Pharmaceutical Water Generation, HVAC, Pharmaceutical Water Storage and Distribution, Cleaning Validation Principles, and Oral Solid Dosage Forms. In addition to Witcher and Odum, top industry experts Rebecca Brewer - Dober Group, Jack Chu - Merck, Andrew Collentro - Water Consulting Specialists, and Norman Goldschmidt - Genesis Engineers will share their expertise and answer questions from attendees.

The impact of the recently updated USFDA guidance on Process Validation will be discussed during the classes to provide participants with the tools and knowledge needed to solve daily work-related challenges resulting from the Guidance's significant changes.

Click here for full course descriptions, instructor bios, and registration information. For press passes to attend this event, please contact ISPE Communications Manager Danielle Hould at or call +1-813-960-2105, ext. 277.
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