Discover strategies to navigate complex compliance requirements, initiate CAPAs and support clinical sites for audit readiness. With this webinar you will acquire a clear understanding of how to effectively support your clinical sites for every stage of the inspection process to ensure that regulatory expectations are met and any audit findings are managed effectively.
The expert speaker will share with the attendees how to attain good clinical practice (GCP) compliance for sponsors and clinical sites, including the assessment and improvement of quality management systems (QMS), site qualification, audit and inspection readiness. The identification and mitigation of risks such as protocol deviations, data discrepancies, data protection deficiencies and documentation gaps will also be covered.
Attendees will acquire insights into how to initiate corrective and preventive actions (CAPAs) and/or change control processes as necessary. In addition, this webinar offers attendees guidance on conducting comprehensive reviews of essential records, procedures and other internal quality documentation to ensure overall compliance with regulatory standards, study protocols and procedures.
Register for this webinar today to learn strategies that will assist in supporting clinical sites for audit readiness.
Speaker
Catherine Menard, MSc, RQAP-GCP, LEAN Certified, Vice President, Quality & Compliance, Scimega
Catherine Menard has over 19 years of experience in complex clinical research, ICH-GCP-regulated environments and global settings, with specialized expertise in clinical trials and a robust background in both hospital and biopharmaceutical settings. She practices with high ethical and quality standards and is committed to guiding clients toward building and maintaining high-quality standards and continuous improvement, conducting and overseeing internal, vendor, and third-party audits and inspections, leading GCP audits mandated by clients and offering tailored GCP compliance consulting services.
As an RQAP-GCP and LEAN-certified professional with an MSc in Neurosciences, she has over 8 years of experience in dedicated QA management, GCP auditing and consulting under Health Canada and US FDA regulations with experience across Canada and US, in addition to her international research experience in Europe (Belgium).
Through a LEAN approach within a company culture of continuous improvement, all the engagements that Catherine undertakes for Scimega are proactively focused on challenges, optimizing resources and upholding a high standard of operational excellence.
Message PresenterWho Should Attend?
This webinar will appeal to those in the following fields or having the following job titles:
- Quality assurance
- Clinical operations
- Team leaders from small to mid-size biotech organizations/Clinical sites involved in clinical studies
- Manager/Associate or Assistant Director/Director/Head/Vice President Operations
- CEO/CMO
- Principal Investigator
- Site Coordinator/Site Manager
- QA Representative/Manager/Director
What You Will Learn
Attendees will learn about:
- The flow of activities before, during and after an audit from a clinical site perspective
- The various elements subject to the scope of an audit/inspection
- The areas of higher risk, including common audit and inspection findings
- How to support sites and comply with GCP guidelines
Xtalks Partner
Scimega
Scimega is a niche Canadian oncology CRO acting in Canada within the context of global cutting-edge oncology trials sponsored by mid-size and smaller biotechs. Skilled in collaborative vendor teaming, Scimega guarantees sponsors the quickest site start-up and highest patient recruitment rate, without sacrificing premium quality data.
With an optimal operations design robust enough to address an ever-changing clinical trial landscape, Scimega’s team of Lean Coached oncology experts go above-and-beyond to provide: Local, full-time, permanent hires for exceptional staff quality; An extensive network of Canadian Investigator Sites that frequently emerge among top enrollers, and are activated 50% faster than average for global studies; Optimal site engagement to maximize quality, timely data entry and query resolution; Robust and Lean Scimega methodology and processes are supported by current technology to keep every trial this CRO monitors on the Lean trajectory.
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