This online course/workshop provides an overview of the scope of ISPE's Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment Guide as it relates to risk-based verification. It describes the engineering and quality system structures and changes necessary to support risk-based verification programs; historical background on traditional qualification and need for change within the industry; identifies the industry transition on regulatory, standards and guides that support risk-based verification; and identifies implementation considerations and recommended practices for adopting risk-based verification programs. At the conclusion of this session, participants will have knowledge of:
- The scope of the FSE guide as it relates to risk-based verification.
- Historical background on traditional qualification and the need for change within industry.
- Industry transition in relation to regulatory standards and guides supporting risk-based verification.
- The engineering and quality system structures and changes- necessary to support risk-based verification programs.
- Implementation considerations and recommended practices for adopting risk-based verification programs.
Attendance suggested for:
- Years in industry: 0-4 to 5-14
- This course will be of interest to those following the latest industry and regulatory initiatives, including application product and process understanding within qualification and the science- and risk-based approach with emphasis on commissioning and qualification of equipment and systems.
- Intermediate practitioners of Commissioning and Qualification who want to understand and use the Science and Risk-based approach to Quality Risk Management.
- Project engineers, project managers, commissioning and validation professionals, engineering service providers, and quality assurance personnel involved in qualification and validation and regulatory.
Dan Franklin, CIRM, CxA is the Regional Manager of Integrated Project Services’ Midwest US Commissioning and Qualification operations based in Indianapolis, Indiana. Current responsibilities include consulting; and program planning, delivery and execution support for capital projects and risk-based verification programs. Mr. Franklin has over 30 years of project delivery and operations support experience. Graduated from Lewis University with a Bachelor of Science degree in Aviation Maintenance Management, Mr. Franklin has also earned an MBA degree from National University and a number of industry certifications & licenses. Mr. Franklin supports the ISPE Commissioning & Qualification COP as a Steering Committee Member, and has served as a contributing author to the ISPE FE Guide, the C&Q Applied Risk Management Good Practice Guide, and the ISPE Decommissioning Good Practice Guide. He is also a designated classroom training Instructor for the new ISPE course and workshop; “Risk- Based Verification of Facilities, Systems and Equipment” and for the Baseline Guide 5 course, “Commissioning and Qualification.”