Five Steps to TMF “Inspection Readiness”
Sponsored by Agatha Worldwide
Wednesday, Oct. 27, 2021 | 11:00 AM-12:00 PM EDT
Location: Your office or conference room (no need to travel!)
The days of scrambling to get ready for an audit are gone. Instead, the FDA requires every clinical trial sponsor to be inspection-ready at all times. There’s no longer an option to find missing items, remediate duplicates, or correct errors — but how can you ensure your team is maintaining its study data and content in an organized, error-free manner?
An electronic trial master file (eTMF) application can make this process a success.
The Five Steps to TMF “Inspection Readiness” free webinar on Oct. 27 will explore the real meaning of being inspection-ready and demonstrate why that goal is impossible without a more modern plan. Clinical operations and systems experts Ken Lownie and Janine Penman will discuss the benefits and process of bringing an eTMF application into your organization. They’ll explain what makes a productive eTMF and how you can make the case for implementing this tool.
- Requirements of Being “Inspection Ready”
- FDA guidelines and implications
- The benefits of an eTMF application
- How eTMF applications can improve data and content maintenance
- Implementing an eTMF Solution
- Making the case for an eTMF application
- Choosing the right eTMF application
- Five key capabilities of a successful tool
- Bringing an eTMF solution into your process
With the FDA’s requirement that any clinical trial sponsor be consistently and solidly ready for an inspection, organizations need a better way to organize their data and content. An eTMF application is that way. Discover how integrating this innovative, essential system into your work can streamline any upcoming reviews.
Join us by registering for this free webinar today.
Who Will Benefit:
- Pharmaceutical companies
- Medical device companies
- Biotech companies
- Compliance leadership
- Quality leadership
- Regulatory leadership
- Clinical operations teams
- Clinical operations leadership
Meet Your PresenterS:
Head of Worldwide Operations
Ken Lownie is the head of worldwide operations for Agatha Worldwide. He has more than 20 years of experience working with technology companies to build solutions that support the demands of enterprise companies. Today, he works with life sciences companies to implement technology solutions that automate and accelerate clinical operations processes. He is a frequent writer and speaker on technology adoption in life sciences.
Founder and CEO
Janine Penman is the founder and CEO of JPScientific, Inc. She is a pioneer thinker in the world of eClinical Systems and the Clinical Systems Integration Movement, a paradigm shift in thinking dedicated to connecting currently disparate eClinical Systems to facilitate a truly unified Trial Master File (TMF). She is a subject matter expert in eClinical Systems remediation, clinical strategy, and quality management. She more than 23 years of experience leading culturally diverse global teams across more than 30 markets and is globally recognized as an experienced leader in clinical quality compliance.