Quality Systems: System Validation

Gain an understanding of the purpose, elements, and implementation of contamination control programs, as well as the impact of emerging process, development and control strategies on traditional validation practices. At the conclusion of this online course, participants will have knowledge of:

  • Purpose, elements, and implementation of product, process, facility, equipment, computer system, analytical method, and contamination control programs
  • Impact of emerging process development and control strategies on traditional validation practices

Attendance suggested for:

  • Years in industry: 0-4 to 5-14
  • Ideal audiences are those with 2+ years of industry experience that want to supplement their industry knowledge about a specific topic(s).
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James J. Keane
Sr. Compliance Associate
Tracer Technologies, LLC

James J. Keane has 35 years of experience in manufacturing, development, and quality assurance. His industry experience started with DuPont Medical Products where he assumed many roles including manufacturing supervisor for their tablet and blending operations. In addition, he was responsible for the scale-up of HIV virus for the development of the first diagnostic test kits for AIDS. His experience at DuPont includes a major role in implementing ISO certification and manufacturing resource planning (MPR). In the 1990's he was the director of validation and compliance for several engineering and compliance firms. He has managed numerous validation projects at manufacturing facilities as well as pilot plants. His experience also includes roles in quality assurance where he has been responsible for product release, review of protocols, SOPs, deviation, and the development of CAPA programs. He is a member of ISPE and ASTM. He has assisted in setting up the elements of quality systems in several companies and has conducted cGMP audits of several pharmaceutical, biotech and medical device firms throughout the USA and Puerto Rico and Europe. Since 2003 he has been providing compliance and validation consulting services as president of NorthStar CV, a subsidiary of SNC-Lavalin Pharma.

Ms. Diana M. Knittel-Pace
President
Outsource Inc

Diana Knittel-Pace is an independent consultant with more than 28 years of experience in the pharmaceutical manufacturing industry. As president of Outsource, Inc., her area of expertise is facilities and engineering, with particular emphasis on qualification, calibration, maintenance and engineering. In the early part of her career, Knittel Pace worked on staff for Pfizer and Marion Laboratories. Since 1991, she has worked as a consultant on projects for companies throughout the United States and Puerto Rico, as well as France and Canada. She has worked extensively with the Quantic Group LTD on projects involving consent decree, warning letter, and 483 issues at both corporate and site levels. Knittel Pace received her MBA from the University of Kansas in 1991 and her BS degree in Chemical Engineering from the University of Missouri in 1981. She has served on the ISPE International Board of Directors, is a Past President of the ISPE Midwest Chapter, and has served as chairperson and member of multiple ISPE committees. (July 10)

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