Education Sessions

E-GU2a
Changes to C&Q Baseline® Guide: Incorporating Risk-Based Qualification and Present Day Case Studies of Successful Implementation
(Two Successive Sessions)

6 November 08.15-11.30
6 November 14.15-17.30		 Track: Guides & Guidance Documents

ISPE CEUs: 0.5

As new challenges develop for our industry, ISPE must continue to strengthen its position as the integrator for change in academia, government, and industry. Recently, ISPE developed a new ASTM consensus standard for “risk-based commissioning and qualification,” taking ISPE beyond the realm of baseline guides. In acknowledgement of this accomplishment and our increased role in the development of risk-based standards, ISPE is currently revising the current Commissioning and Qualification Baseline® Guide. The ability to disseminate this knowledge as it unfolds has certainly created a competitive advantage for our membership. Toward this end, this series of education sessions was established in order to provide our membership advanced information on these initiatives.

ISPE has been at the forefront of developing practice that impacts your ability to deliver today. Near the turn of the decade, ISPE published the current C&Q Baseline Guide: Baseline Pharmaceutical Engineering Guides for New and Renovated Facilities – Volume 5: Commissioning and Qualification.

This Guide brought much needed change to how the industry approached commissioning and qualification. It introduced tools and concepts such as impact assessments, critical vs. non-critical components, and design for impact. The Guide has served the industry well, but is in need of being updated. Become part of transforming tomorrow as the industry continues to move toward a science- and risk-based approach to facility delivery, and full integration of commissioning and qualification activities.

Join this session to analyze current progress on the Guide update, and contribute to the discussion on the changes planned. Hear from authors of the proposed standard and from case studies on how concepts from the proposed ASTM standard on a Science and Risk-Based Approach to Qualification of Biopharmaceutical and Pharmaceutical Manufacturing Systems is being used with success, how to apply this to your work today, and how it can help you deliver even better tomorrow.

Take Back to Your Job

  • Understand why an update to the C&Q Baseline Guide is now needed and how changes to the Guide provides for more efficient project delivery
  • Know the link between a risk- and science-based approach to C&Q and Quality by Design
  • Apply successes related to ASTM 55.03 to your work

Who Should Attend

Those involved with the planning, execution, oversight, and approval of commissioning and qualification activities. This includes, but is not limited to, project managers, facility and process engineers, validation, quality assurance, and manufacturing personnel.

Communities of Practice: Commissioning and Qualification (C&Q), Project Management (PM), Process/Product Development (PPD), and Good Automated Manufacturing Practice (GAMP)

Session Leaders

Session Speakers

  • John Robert Adamson, Mgr Compliance & Validation, Foster Wheeler Energy Ltd
  • Joerg Block, PS-TS-KM-Tech Compliance, Bayer HealthCare AG
  • Robert Chew, President, Commissioning Agents, Inc.
  • Peter Christensen, Quality Professional, NNE Pharmaplan A/S
  • Petter Gallon, Risk Analyst, AstraZeneca AB
  • Rick Gunyon, Quality Eng Consultant, Eli Lilly and Co
  • Lori Kim, Manager, GPO Engineering, Abbott Laboratories
  • Tulsa Scott, Regional Manager, Commissioning Agents
  • Steven Wisniewski, Sr Associate Dir of Compliance, IPS
  • Graham Wrigley, Senior Mgr/Team Leader, Pfizer
  • Stephen Yu, Principle Process Engineer, BE&K - Delaware

 

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