Commissioning and Qualification as a Risk Management Strategy

Session Type: Recorded Webinars
Knowledge Element: Facilities and Equipment
Speaker: Tim Howard, PE
Duration: 30 minutes

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This course provides an overview of success factors for Commissioning and Qualification projects. It examines key planning steps at the program level and important system level activities that occur prior to construction. These activities define the critical attributes and acceptance criteria for subsequent qualification activities. The activities that take place during construction and fabrication, as well as post installation are also reviewed. For each activity, the documentation required and responsible party is reviewed. Finally, this course takes a look at the future, discussing principals found in ASTM standard E2500.

Learning Objectives:

• Discuss the planning documents that can impact the success of a C&Q project 
• Understand the importance of User Requirements and how they contribute to successful project delivery 
• Describe multiple methods for conducting design review or design qualification 
• Discuss System and Component level impact assessments, and how the information is used. 
• Understand the risk abatement opportunities that exist throughout the C&Q lifecycle of a project. 
• Discuss typical pre and post equipment delivery C&Q activities including activity sequencing, documentation, and accountable parties. 
• Understand how ASTM E2500 offers an opportunity to stream future C&Q efforts.

Who Should Attend:

• Pharmaceutical professionals impacted by, or supported by C&Q efforts – but not directly accountable for the C&Q phase (development scientists, regulatory affairs professionals, manufacturing manager and leaders, etc.) 
• Pharmaceutical professionals that have limited knowledge of commissioning and qualification. 
• Pharmaceutical professionals looking for a refresher on success factors in C&Q projects.

Speaker Biography

Timothy Howard, PE, has more than 12 years of experience in pharmaceutical and biotechnology plant commissioning, qualification, and validation. He spent 3½ years with Eli Lilly at a green field site, responsible for leading the C&Q effort and later the maintenance and facility. He has been active with ISPE since 1996, is a former board member of the Carolina-South Atlantic Chapter, has served on the North American Education Committee since 2002, and is the current co-chair of the NAEC. He is a former naval nuclear submarine officer, and was previously licensed as a senior reactor operator on a commercial nuclear power plant. Howard earned a B.S. degree in mechanical engineering from N.C. State University and is a registered professional engineer in North Carolina.

What is a Recorded Webinar?

Previously held webinars are available as recorded sessions, which you can view at your convenience. Registration orders are processed within two business days, after which participants will receive an email confirmation with a link to the Recorded Webinar. After receiving the link to the Recorded Webinar, you have 15 days to view it.

What are CPIP^SM Recorded Webinars?

CPIP^SM Recorded Webinars are a group of Recorded Webinarswas developed to help individuals in preparation for the Certified Pharmaceutical Industry Professional^SM (CPIP^SM) examination.

The Certified Pharmaceutical Industry Professional^SM (CPIP^SM) credential recognizes “change agents” as the necessary ingredient to foster industry innovation and enhance drug product quality. The credential establishes a global competency standard for industry professionals, and candidates are assessed through demonstrated education, experience, and a rigorous examination. Completion of any of these seminars does not guarantee successful completion of the CPIP certification exam, and these seminars do not include every subject to the depth of what will be covered on the CPIP exam.

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