Review the purpose, elements, and implementation of quality management systems, and risk management strategies. Highlights include a review of change control, CAPA, and internal assessment programs. At the conclusion of this online course, participants will have knowledge of:
- Change control programs
- CAPA programs
- The elements of an internal assessment program
- Risk management strategies
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).
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.