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CfPA-The Center for Professional Advancement, New Brunswick, NJ
September 24, 2015
Who Should Attend?
This introductory/intermediate course is designed for individuals who need a basic, but thorough understanding of key principles of Quality Risk Management (QRM) and how to apply them over the product/system life cycle and within Quality Systems.
The course will benefit individuals in:
• Engineering
• Technical Services/Validation
• Production
• Quality Control/Assurance
• R&D
• Regulatory Affairs
• University and allied health care professionals Course Description
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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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| Steven J. Wisniewski; Principal Consultant, CAI Consulting |
Steven J. Wisniewski is Principal Compliance Consultant for CAI Consulting, provider of consulting services for biotech and pharmaceutical manufacturers world-wide. CAI Consulting focuses on the manufacturing process, with services including commissioning, validation, technology transfer, owner project management, maintenance programs, SOPs, training and cGMP compliance.
Mr. Wisniewski offers more than 30 years experience in the pharmaceutical, biotech, and device industries. Prior to joining CAI he was Senior Associate and Director of Compliance for IPS. Mr. Wisniewski has served in senior management roles at Sterling Winthrop and Bausch & Lomb. He has completed a wide variety of pharmaceutical manufacturing, filling and critical support operations to major R&D laboratories, facilities and upgrades. He holds a BSME from Rensselaer Polytechnic Institute, is a Member of PDA, and an active Member of ISPE. He served on the ISPE board of directors beginning in 1982, and was chairman of the board in 1991. He served four terms as Chairman of the ISPE Community of Practice for Commissioning and Qualification, was a lead on the Task Team that drafted the ISPE Guide in support of Risk-based Qualification and served on Task Team that completed the ISPE Good Practice Guide to address transitional Science and Risk-based (ICH Q9) approaches for C&Q. He was on the Team that developed the ASTM E2500 Standard and has also served as course leader and/or presenter at multiple ISPE conferences and co-authored several C&Q related articles.
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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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This one-day, intensive course will introduce the key principles of QRM across the product/system life cycle and within Quality Systems. Topics discussed include an introduction and overview of Quality Risk Management, philosophy and application of a holistic QRM process; an overview and appropriate use of risk assessment tools; the application of risk management methodologies throughout specification, design, verification, and manufacturing. Course workshops will include use of risk assessment tools and developing the structure of a site QRM Program.
Maximize Your Learning!
Attend this course and its Companion Course:
IQ, OQ, PQ
September 22-23, 2015 • New Brunswick, NJ • Course ID #1808