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  November 05, 2012  
CfPA - The Center for Professional Advancement, New Brunswick, NJ
November 28-29, 2012

Who Should Attend
This introductory/intermediate course is designed for individuals who need a basic, but thorough understanding of the Qualification Process for equipment and systems in support of Process Validation for the manufacture 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

The installation/operational/performance qualification/ verification 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 and facilities must be accepted as fit for use, 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 critically assessment is also provided along with an overview of ICH Q9 Quality Risk Management and ASTM E 2500 International Consensus Standard approaches now being applied by the Industry and Regulatory authorities to define Qualification (Verification) requirements.

Protocol examples/workshops will be utilized to enhance the learning, however this course will not provide a library of completed protocols.

Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: 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 worldwide. 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 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 C&Q conferences and co-authored several C&Q related articles.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
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