Agenda at a Glance
Tuesday, November 2, 2021
All Times in Pacific Standard Time
Key TMF Management Areas to Adapt to when an Inspection is Conducted Remotely
Remotely conducted health authority inspections are currently necessitated due to the COVID-19 pandemic. However, components of remotely conducted inspections will remain embedded in the future inspection process well beyond the current situation. To ensure that your company is ready for a remote inspection, it must assess current inspection-related processes to be flexible to host one that is conducted all or partially remote. During this interactive workshop we, from a TMF management focus, will:
- Identify the areas of biggest change when some or all of an inspection is conducted remotely
- Identify core elements that will need to be changed when all or portions of an inspection is conducted remotely
- Review why the technology aspect of inspections is so much more important and how to support all of those involved
- Explore strategies for how to prepare your organization for the provision of content to be reviewed by remotely located inspectors
- Examine suggestions for preparing for virtually conducted inspection interviews
Mulcahy Consulting, LLC
Main Conference Day One
Wednesday, November 3, 2021
Just what exactly IS an Electronic Document Management System (EDMS)? And why do you need one to manage your Regulatory Documentation? Won’t an EDMS automatically manage my documents? We will answer these questions and more in Operational Procedures and Tools for your Electronic Document Management System (EDMS).
To manage your EDMS, you need more than just the system user guide that explains how to perform the various system functions, i.e. Click Here, Select your Files, Click OK. You need Operational Procedures that define how your team will use the EDMS to accomplish its goals. Furthermore, you need Operational Tools that help you manage your documentation using the EDMS.
This session will cover why you need an EDMS and how to properly utilize your EDMS to accomplish your teams’ goals.
- Start your program with the proper documentation structure in place
- Be prepared for the workload of Regulatory documentation
- Standardize your document formatting – neatness equals clarity to the Competent Authorities.
- Standardize your tools for accuracy and speed
- Make the EDMS less stressful and less intimidating for your colleagues
Regulatory Documentation Specialist
- Strategies to understand all stakeholders scope of work and engagement to enhance collaboration
- Review SOP to ensure quality in document review
- Ensure efficient trial management through effective management
- Improve GCP through proper review through quality requirements
- Ensure an inspection ready-ready TMF
Texas Heart Institute, Center for Clinical Research
Main Conference Day Two
Thursday, November 4, 2021
Main Conference Day Three
Friday, November 5, 2021
- How open and transparent partnership allow collaborative strategies for successful TMF Management.
- TMF as a Priority: Ensuring accountability
- Implementing lessons learned for successful partnership.
Senior, eTMF Specialist
Global Blood Therapeutics
Director, TMF Operations