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CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training
February 15, 2012 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This online training will benefit professionals in the following industries: Pharmaceutical, Biotechnology, and Medical Device.
In departments such as:
QA/QC/RA, Manufacturing/Operation, Research and Development, Legal, Engineering
With job functions:
Department Managers and Supervisors, QA/QC/RA Specialists and Engineers, Manufacturing and R&D Engineers, Chemists, Scientists, Formulators, Documentation Specialists, Auditors, Technicians Description
Equipment Qualification has come under intense scrutiny by the FDA in recent years and is undergoing a significant change by the application of the Quality Risk Management principles described in ICH Q9. This 90-minute accredited online training course will examine the new industry/FDA QRM environment and will give you tools for survival; it will provide a step-by-step guide to planning and preparing for equipment qualification and includes a discussion of how to conduct and document qualification (verification), handle deviations, prepare summary reports and “maintain the qualified state”.
Further, this course provides “content understanding” so important for auditing qualification activities as required in today’s FDA QRM regulated industry environment.
Review of Learning Objectives
Module 1:
• Background-Regulatory Requirements
• Why do I need to qualify equipment?
• What is equipment qualification?
Module 2:
• Qualification Basics; QRM based approaches
• Execution and Documentation Basics
Module 3:
• Handling Deviations
• Summary Reports
• When do I need to do all this?
• How do I “maintain the qualified state?” and lifecycle
implications
Question and Answer Session
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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 Compliance Consultant, Commissioning Agents, Inc. (CAI)
Steven J. Wisniewski is Principal Compliance Consultant for Commissioning Agents, Inc. (CAI), provider of technical services for biotech and pharmaceutical manufacturers world-wide. Commissioning Agents focuses on the manufacturing process, with services including commissioning, validation, technology transfer, PAT, 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 new ISPE Guide in support of Risk-based Qualification and served on Task Team that just completed the ISPE Good Practice Guide to address transitional Science and Riskbased (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 C&Q 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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