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The Center for Professional Advancement, New Brunswick, NJ
June 17-18, 2008
Who Should Attend
This introductory course is designed for individuals who need a basic, but thorough, understanding of the Validation Process for equipment and processes used in the manufacturing of pharmaceutical sterile and oral solid finished dosage forms, and bulk active ingredients through the use of IQ/OQ/PQ Protocols. The course will benefit individuals in:- Engineering
- Technical Services/Validation
- Production
- Quality Control/Assurance
- R&D
- Regulatory Affairs
- University and allied health care professionals
Description
The installation/operational/performance qualification of equipment, systems, facilities, and processes for pharmaceutical sterile, oral solid dosage, finished and bulk manufacturing operations are an essential part of the validation process. Equipment must be installed, operated, and maintained within design specifications, while processes must be shown to be reliable, all of which to assure the consistent quality and integrity of the product. This course provides a basic and thorough understanding to preparing, executing, reviewing, and approving protocols. A Risk Based approach to impact and critical component assessment is also provided along with an overview of the current on-going activities to provide International Consensus Standards being considered by the Industry and Regulatory authorities to define future Qualification requirements. Protocol examples/workshops will be utilized to enhance the learning, however this course will not provide a library of completed protocols.
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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 J. Wisniewski, Senior Associate and Director of Compliance, Integrated Project Services (IPS)
Steven J. Wisniewski is a Senior Associate and Director of Compliance for Integrated Project Services (IPS), a full serviceengineering 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 then 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 revising the ISPE Baseline Guide for C&Q.
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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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info@cfpa.com
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