ASK US: Equipment and calibration

What is the relationship between equipment, Good Manufacturing Practices and Good Clinical Practice at a clinical trial site?

Regulatory, quality and risk management requirements run continuously for all product and equipment lifecycles, from thermometers to scales to freezers. In this ASK US session, we will answer your questions on the components of effective equipment management. This includes regulatory requirements, service provider or vendor expectations, documentation and common equipment inspection findings, compliance, and more.

Our guest speaker for this episode is Karen McGillivray, quality lead, Provincial Clinical Trials at BC Cancer. Responsible for quality oversight at 6 provincial BC Cancer centres, Karen brings nearly 20 years of experience in clinical quality. She will join a lively fireside chat with our host Jean Smart, regulatory affairs & quality officer at Clinical Trials BC. Together, they will answer your questions, share personal anecdotes on best practices for equipment management, and share some tips on compliance.

Join us for our final episode of ASK US Season 5 on this engaging and practical discussion on equipment and supplies for clinical trials.

Learning objectives

The learner will be able to:

• understand the relationship between Good Manufacturing Practices and Good Clinical Practice at clinical trial sites
• understand the requirements and importance of equipment management and the various components associated with it
• discuss the best practices for meeting compliance for equipment and supplies in a clinical trial

Host:

Jean Smart, regulatory affairs & quality officer, Clinical Trials BC, Michael Smith Health Research BC

Guest Speaker:

Karen McGillivray, quality lead, Provincial Clinical Trials, BC Cancer

Karen is the Quality Lead, Provincial Clinical Trials at BC Cancer, responsible for quality oversight at 6 provincial centres. She has over 18 years of experience in clinical quality and has previously worked for both a sponsor company and a CRO, allowing for a well-rounded view of Good Clinical Practices. Karen specializes in quality management, SOP creation, and computer system validation, and conducted GCP audits both domestically and internationally. She has played a significant role in the development and expansion of RealTime CTMS use at PHSA and provincially. She has maintained her credential as a Registered Quality Assurance Professional in Good Clinical Practices since 2008.