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ISPE

FDA Compliance

Biotechnology and GMP Courses Featured at ISPE Training Event

Biopharmaceutical manufacturing practices, compliance issues explained by industry experts

Published: Tuesday, February 1, 2011 - 17:09

(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, will offer seven training courses, including sessions focusing on biotechnology and good manufacturing practices (GMP), at its San Francisco Professional Development Training, March 7–10, at the Hotel Monaco San Francisco. This marks the first time the ISPE training event has returned to the San Francisco area since 2007.

As a member-based organization, ISPE draws from the expertise of its 22,000 members to develop training courses that address industry demands and 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, Ph.D. 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 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 U.S. Food and Drug Administration’s (FDA) 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.

The San Francisco Professional Development Training event will also feature the following courses:
• Pharmaceutical Water Generation (T04)
• HVAC for Pharmaceutical Facilities (T14)
• Cleaning Validation Principles (T17)
• Oral Solid Dosage Forms: Process Monitoring Techniques and Challenges in Scale-Up and Technology Transfer (T10)

 

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 FDA Guidance for Industry Process Validation: General Principles and Practices 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.

Full course descriptions, instructor biographies, and registration information can be found at www.ISPE.org/2010SanFranciscoTraining

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ISPE

The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association of 22,000 pharmaceutical professionals in 90 countries who use knowledge to create high-quality, cost-effective good manufacturing practices (GMP) solutions. ISPE provides its members opportunities to develop 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 for a global audience. Its world headquarters are in Tampa, Florida, with offices in Brussels, Belgium, Shanghai, China, and Singapore.