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CfPA - The Center for Professional Advancement, East Brunswick, NJ
October 21-22, 2013
Who Should Attend
This course has been designed for individuals who have a general understanding of cGMP operations and want to learn more about proposing, designing, launching, and operating a RBT system. Personnel working for pharmaceutical and biotechnology companies in the following functions should attend:
• Clinical Manufacturing
• Commercial Production
• Management
• Process Development
• Quality Assurance
• Quality Control
• Training
• Validation Description
Current Good Manufacturing Practice (cGMP) requires that each person engaged in the manufacture, processing, packing, or holding of drug product shall have training to enable that person to perform the assigned functions. ICH Q9, Quality Risk Management, explains risk management and suggests that level of effort should be commensurate with the level of risk to patients.
This intensive, interactive two-day course will review the components of a cGMP-compliant training system and present the benefits of a system that optimizes resources by ensuring that the level of training effort is commensurate with risk. While risk to patients is the key consideration for all pharmaceuticals and biological drug products, the course will also address risk to personnel, environment, and business operations. Critical activities required for justification, design, launch, and operation of a RBT system will be discussed and applied during in-class workshops.
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Organized by:
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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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Rick Lawless, CPIP; Associate Director, Strategic Programs, NC State University
Rick Lawless, CPIP, has been working in the biotechnology industry since 1985. More than 18 of those years were spent in cGMP-regulated environments at Johnson & Johnson Ortho Clinical Diagnostics and Wyeth Vaccines. During that time, he directed manufacturing operations, managed start-up of new facilities, and was member of a team tasked to implement enhanced corporate-wide quality systems in response to a consent decree. In 2006, he joined NC State University to help design, start-up, and operate the Biomanufacturing Training and Education Center (BTEC). In his current role as Associate Director, Strategic Programs, he teaches courses in quality systems and regulatory affairs, and is responsible for projects that grow and enhance BTEC’s capacity and capabilities. Mr. Lawless received a B.S. in Microbiology and a B.S.E. in Chemical Engineering from the University of Michigan, Ann Arbor. He also obtained a MBA from State University of New York at Buffalo. He is a member of ISPE and its Professional Certification Commission that oversees the CPIP credential.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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