Sponsors are responsible for vendor oversight, but how is this accomplished? Sponsors are outsourcing more clinical research processes, and they need to have both the team and processes in place to bring on vendors and manage them to be compliant and ensure a cohesive team approach.
This presentation will instruct the participant on how to ensure the correct vendor for their organization and clinical study. The process starts with a cohesive team for the sponsor to define vendor specifications, internal and external planning, pre-selection, evaluating, negotiation, contracting and selection.
It will begin with a regulatory overview of sponsor responsibilities This will be followed by explanation on how to choose the right vendor. Finally, Best Practices for creating, implementing and maintaining tools to ensure the correct vendor is chosen for the sponsor requirements.
Why should you attend:
FDA Regulations and ICH E6R2 guidelines note requirements for vendor oversight. This does not mean after signing the contract with the vendor, your team finds out they are not compatible or can not provide the full services needed for the study. The sponsor needs to have internal analysis and planning processes to define requirements for choosing the right vendor up front.
This webinar will show you how to choose the right vendor, onboarding and set up, manage vendor performance, manage issues and ensure compliance with current FDA regulations and ICH guidelines and have a smooth-running clinical study.
- Vendor oversight - what do the regulations mean?
- Vendor management as a team approach
- Defining requirements
- Use of Tools and Processes
- Managing vendor performance
Who will Benefit
- Contract VP
- Quality VPs
- IT VPs
- Contract personnel
- Regulator Affairs professionals
- Quality Managers
Industries who can attend
This 90-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.
Faculty Angela Bazigos
Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance.