Facilities and Equipment: Commissioning and Qualifications as a Risk Management Strategy

This online 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. At the conclusion of this session, participants will have knowledge of:

  • Factors that can impact the commissioning and qualification process
  • Requirements for executing and documenting the commissioning and qualification
  • Concepts, sequencing, and documentation of commissioning and qualification activities required by design intent
  • Critical systems impact assessment and implications for the product


  • Years in industry: 0-4 to 5-14
  • Ideal audiences are those with 2+ years of industry experience that want to supplement their industry knowledge about a specific topic(s).

Timothy Howard, CPIP, PE, has over 13 years of experience in pharmaceutical and biotechnology plant commissioning, qualification, and validation. He is currently the C&Q Business Area Lead for Commissioning Agents, Inc. Previously he was with Eli Lilly at a green field site, responsible for leading the C&Q effort and later the maintenance and facility engineering departments. He has been active with ISPE since 1996, is a current 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. Mr. Howard earned a B.S. degree in Mechanical Engineering from N.C. State University, is a Certified Pharmaceutical Industry Professional, and is a registered professional engineer in North Carolina.



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