ROUNDTABLE Industry Site Qualification and Surveillance Audits: Is Standardization the Answer?
Wednesday, May 31, 2023 02:15 PM - 03:15 PM
Room 242B
Regulation & Reimbursement
Roundtable
Can these audits be standardized to optimize human and financial resources without reducing their quality?
Moderator
Phyllis Warkentin, MD, Medical Director, Biologics Production Facility, University of Nebraska Medical Center, USA
Panelists
Liz Ferraro, BA, Manager, Auditing Services, Foundation for the Accreditation of Cellular Therapy, USA
Peter Holman, MSc, Vice President of Quality, ArsenalBio, USA
Session Description
Site qualification and surveillance audits for cell and gene therapies are often required by local regulations or internal quality systems. Audit processes have typically been developed by individual companies and vary widely. The result is duplicative, and sometimes conflicting, requirements. Participants in this roundtable will use their experience conducting audits or being audited to ask the Five W’s – who, what, when, where, and why – to generate ideas for how industry audits could be streamlined to better manage the financial and personnel resources required. All stakeholders are welcome, from industry representatives to health care personnel and in between.
Learning Objectives
Moderator
Phyllis Warkentin, MD, Medical Director, Biologics Production Facility, University of Nebraska Medical Center, USA
Panelists
Liz Ferraro, BA, Manager, Auditing Services, Foundation for the Accreditation of Cellular Therapy, USA
Peter Holman, MSc, Vice President of Quality, ArsenalBio, USA
Session Description
Site qualification and surveillance audits for cell and gene therapies are often required by local regulations or internal quality systems. Audit processes have typically been developed by individual companies and vary widely. The result is duplicative, and sometimes conflicting, requirements. Participants in this roundtable will use their experience conducting audits or being audited to ask the Five W’s – who, what, when, where, and why – to generate ideas for how industry audits could be streamlined to better manage the financial and personnel resources required. All stakeholders are welcome, from industry representatives to health care personnel and in between.
Learning Objectives
- Examine industry audits by asking the Five W’s.
- Discuss ways industry audits can be streamlined to avoid duplicative work while still fulfilling their purpose.
- List ideas for effectively managing audits both at the industry level and at the site level.
Liz Ferraro BA
Manager, Auditing Services
Foundation for the Accreditation of Cellular Therapy
Panelist
Manager, Auditing Services
Foundation for the Accreditation of Cellular Therapy
Panelist
