Trial Master File Inspection Readiness:
From Chaos to Calm
A Free CenterWatch Webinar | Sponsored by Just in Time GCP
Tuesday, Sept. 13, 2022 | 1:30 PM-2:30 PM EDT
Location: Your office or conference room (no need to travel!)
Invalid study data … losing time and effort because your trial master file (TMF) is not inspection ready … a stopped approval for lack of evidence of study conduct …
If the prospect of a TMF inspection causes stress, you need this free webinar.
Is your TMF completely accessible, accurate and complete? Do you have a plan if it isn’t.
Are you confident that your team is ready come inspection time, following the appropriate procedures and able to confidently answer the inspectors’ questions? What if none of them have gone through the process before?
Laura Wiggins, Just in Time GCP’s TMF Services Project Manager, will help you understand your preparedness gaps and create a plan. She’ll take the stress out of your TMF inspection, explaining how to organize and mobilize your people for a smooth inspection. Yes, even an inexperienced team can benefit from new perspectives.
Laura will discuss where to start and share streamlined strategies you can use to move your team from inexperienced to inspection-ready.
Her session will help you go from chaos to calm by exploring how to assess your inspection readiness, revealing risk-based tools and approaches you’ll need, and sharing ways to manage the time and resource constraints you’ll likely face.
- Overcome the main challenges of inspection preparedness, including lack of experience with regulatory inspections, lack of understanding regarding record requirements and poor documentation
- Know what to do when you’re missing TMF documentation, don’t have a study team or when you’ve had a lack of study oversight
- Use strategic thinking models to help you prepare
- Discover practical approaches to get inspection-ready, including developing an inspection-day strategy, a plan for reviewing and ensuring your documentation is compliant/accurately tells your study’s story, and conducting mock interviews and mock inspections
- Discover new perspectives to assist you in considering alternatives, validating your assumptions and knowing when to seek advice from experts
You can’t afford to fail your next inspection. Get your TMF — and your team — inspection-ready the low-stress way with this free webinar. Join us by registering today.
Who Will Benefit:
- Clinical study managers/directors
- Quality assurance directors/inspection
- Vice president of inspection/vice president of clinical
- Clinical operations staff
- Site directors/investigators
- Study leads/study coordinators
- Clinical research coordinators
- CEOs of emerging pharmaceutical/biopharma companies
Meet Your Presenter:
Trial Master File Services Project Manager
Just in Time GCP
Laura Wiggins, Just in Time GCP’s TMF Services Project Manager, is an experienced clinical research project manager who works with clients to analyze, develop and implement processes that support the business use of electronic clinical systems. She is skilled at coordinating the management of the TMF, including process and business document development, systems implementation, migration and validation support. Ms. Wiggins has over 15 years of clinical research experience including TMF management. She is adept at implementing new technologies and methods to increase participant recruitment and deliver quality clinical system and TMF solutions.