Preparing for Investigator Site Inspections: Site & Sponsor Perspectives
A Free CenterWatch Webinar | Sponsored by Just in Time GCP
Wednesday, Oct. 12, 2022 | 1:30 PM-2:30 PM EDT
Location: Your office or conference room (no need to travel!)
Want to take the stress out of site inspection readiness?
Whether you are a sponsor helping your investigator sites plan for an inspection, or an investigator site anticipating an inspection, this free webinar will help you put in place a plan to minimize inspection day surprises and ensure your team is well prepared.
While a site inspection can be intimidating under the best of circumstances, it’s even more so when the site is not fully prepared.
This free webinar will provide a strategy for sponsors to support investigator site preparation and investigator sites to ensure their team is prepared and confident.
Using real-world examples of recent FDA findings, Marion Mays, Just in Time GCP’s Vice President of Inspection Readiness, will share her experiences in supporting numerous sites in preparing for and managing their inspections. There is nothing more stressful than facing a situation ill prepared. She will give you ideas on what to expect during an inspection and what trips people up most. She’ll share strategies you can use to familiarize your team with the inspection process and support them in getting inspection-prepared.
Marion will help you understand where the site may have inspection risk and how to minimize these risks by understanding the story of the study at the site. Her presentation will provide specifics so you and your team can identify risk and confidently answer the inspectors’ questions.
- How to overcome your primary inspection-preparedness challenges, including staff who have minimal inspection experience or may not have even been involved in the study
- Where to focus inspection preparation activities
- How to mitigate findings and how to speak to issues and compliance
- Practical approaches for preparedness, including determining the story of the study, preparing for inspector interviews, and creating a strategy for inspection day
- How to review the study documents using new perspectives that can reveal the gaps
- When to seek advice from a consultant who supports sites in inspection preparation
No one wants inspection findings. Minimize findings by getting yourself, your team and your site inspection ready with this free webinar. Join us by registering today.
Who Will Benefit:
- Sponsors and investigator site staff
- Site investigators
- Site directors
- Clinical research coordinators (CRCs)
- CRAs/site monitors
- Quality Assurance
- Clinical operations staff
- Clinical study managers/directors
- Executive leadership at pharmaceutical/biopharma companies
Meet Your Presenter:
Vice President of Inspection Readiness
Just in Time GCP
Marion Mays, Just in Time GCP’s Vice President of Inspection Readiness, has over 30 years of experience in the life sciences. Her unique combination of both strategic and operational abilities combined with creative thinking make her an ideal advocate for quality through essential information management practices, supporting the advancement of clinical outcomes. Marion develops and implements enterprise-wide programs and technical systems in regulated environments. She has in-depth experience with quality and compliance processes in the pharmaceutical industry, with a focus on supporting organizations through GCP regulatory inspections with the FDA, MHRA, EMA and PMDA.