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The Center for Professional Advancement, 90 minute Accredited Online Training
March 24, 2009 at 11:00 a.m. - 12:30 p.m. (EST)
Who Should Attend
This course is intended for Engineering Unit Managers and interdisciplinary Project Team Members who are responsible to deliver “Fit for Intended Use” cGMP manufacturing, R&D, and supporting facilities. The course is recommended for:
• Engineering Managers
• Project Managers
• Quality Unit Managers
• Commissioning & Qualification Project Team Leaders
• Engineering Design Service Providers
• Construction Managers
• Compliance Service Providers
Description
This 90-minute accredited online course is aligned with current industry “Risk-Based” initiatives and guidance provided in ICH Q9, ASTM E2500, and ISPE Baseline & Good Practice Guides. This course will provide insight on critical project decision making and enable a project team to identify and document data during the application of GEPs during the design, specification, and verification phases of a project. Discussions will focus on identifying and implementing Engineering Quality Systems to assure efficiency and quality.
Module 1:
• GEP Overview
• Engineering Quality Systems
• GMP and GEP
Module 2:
• Design Review Process
• Change Management
• Risk Management
Module 3:
• Applying GEP to the Verification (Commissioning
& Qualification)
• Integrating the Project and Engineering Lifecycles
• Planning for Success
Question and Answer Session
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Steven Wisniewski, Senior Associate, Director of Compliance Services, IPS (Integrated Project Services)
Steven J. Wisniewski is a Senior Associate and Director of Compliance for Integrated Project Services (IPS), a full service-engineering firm specializing in the delivery of technical complex projects, which offers complete design/build, commissioning, validation and FDA compliance services for the pharmaceutical, biotech, health care and specialty manufacturing industries.
He offers more than 30 years experience in the pharmaceutical, biotech, and device industries. Prior to joining IPS, Mr. Wisniewski was Senior Consultant for Drug and Device Associates and 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 served as a member of the ASTM Task Team that developed the International Consensus Standard for Verification (C&Q). Mr. Wisniewski 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, served as Chairman of the Board in 1991 and currently serves as Chairman of the ISPE Community of Practice for Commissioning and Qualification and also serves on a Task Team in the process of drafting the new ISPE Baseline Guide for Installation and Verification (C&Q).
ADDITIONAL FACULITY:
Chuck Stock, Senior Vice President, IPS
Vince Cebular, Senior Director of Operations, Compliance Services, IPS
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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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salbers@cfpa.com
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