ISPE announced a partnership with National Institute for Bioprocessing Research and Training (NIBRT) for a new training course, Commissioning and Qualification (C&Q) for New and Renovated Facilities: Guidance and Improvements for Successful Delivery. This training course will launch 16 – 17 May 2017 at the NBIRT facility in Dublin, Ireland. This new course will provide classroom experience at the NIBRT facility and leverage the current pilot plant to ensure knowledge transfer of C&Q content.
“ISPE continuously strives to support our members and industry in staying ahead of the curve on various technical and operational solutions for pharmaceutical and biopharmaceutical manufacturing,” said John Bournas, ISPE CEO and President. “Our partnership with NIBRT further supports our mission by providing ISPE members with a European learning base that leverages innovative training from a prominent organization.”
This training course is constructed to amplify the way the industry approaches regulated manufacturing capacity: improving the ability to meet documented process requirements, control risks within the manufacturing process, produce high quality products, and consistently operate to meet product and process requirements. The course covers an array of topics including: understanding and developing User Requirements, Risk Management Methodologies, Design Reviews, Quality Risk Management(QRM), Verification Strategy, Acceptance and Release Reports, Change Management and a regulatory review of EU Annex 15 for Qualification and Validation, International Council for Harmonisation (ICH) Guides Q8 (R2), Q9, and Q10, and ASTM Standard E2500-07: Standard Guide for the Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.
The instructors for the course include: John Henchion, Qualified Person, Commissioning Agents, Inc,. and Neil Lloyd, CQV Lead, Clean Utilities & HVAC, LSCC Biologic Project: Bristol-Myers Squibb. The NIBRT facility is a purpose-built, multi-functional building which replicates the most modern industrial bioprocessing facility.
Participants will receive two days of topic-specific, in-depth learning, and skill building. Training include lectures, group exercises, and case studies that provide participants with practical information they can immediately apply to their job. The courses are suited for development, manufacturing, engineering, quality, and validation professionals.
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