October 23rd, 2014
Paul Crissman, Biotechnical Solutions
Dona Tseng, Sr. Principal Engineer, Baxter Healthcare
Baxter Healthcare, 4501 Colorado Blvd., Building 6
Los Angeles, CA 90039
Journey towards a fully mature risk-based approach for commissioning and qualification of equipment and facilities
Phil Bowles, Director Engineering, Amgen Inc
Implementing a risk-based approach to commissioning and qualification based on ASTM E2500 offers significant advantages to manufacturing companies which are demonstrated through a case study for recent large biopharmaceutical capital projects. Delivering these benefits also requires a range of technical, quality and organizational challenges to be overcome, particularly in how to apply the guiding principles from the E2500 standard guide. Some of these challenges are addressed along with discussion of “where next” on our journey towards a fully mature risk-based approach for commissioning and qualification of equipment and facilities.
Verification, SME Leveraging & Life Cycle Data Harvest:
The Project Information Supply Chain’s key role in the path to ASTM E2500 implementation
Rick Kramer, President, CPFS
Life Science manufacturing companies are advancing their ability to fully realize the benefits of ASTM E2500. To do so, requires the next evolution of cultural acceptance, as well as innovative tools and methodology. Qualifying the OEM vendor supply base to participate as SME’s enhances overall GEP and realizes cost benefits and project execution efficiency. A front loaded approach to aligning the Risk Based C&Q strategy with the Project Information Supply Chain allows the intelligent harvest & dissemination of critical Qualification Information, and key Life Cycle Data in support of owner Compliance and OpEx.
Steps Along the Way: Best Practices and Pitfalls to Avoid in E2500 Implementation
Robert Chew, President, Commissioning Agents Inc.
The pharmaceutical industry is still sorting out best practices for implementing an ASTM E2500-based approach to commissioning and qualification. Through our work with numerous customers, we have seen some approaches that have worked well, and other approaches that resulted in a variety of unforeseen obstacles to overcome; we will discuss examples of both. In addition, some of the special challenges of implementing a risk-based approach for companies that already have a mature traditional commissioning and qualification program in place will be covered. Finally, we will discuss some of the tools that have proven to be useful on a variety of projects.