This webinar will provide step-by-step considerations for finding potential vendors, implementing a robust qualification & selection process, strategies for oversight and management of vendors, and a risk mitigation approach for key vendors.
GxPs are required to be followed, not only by the sponsoring company, but also by all vendors who are chosen by the company to complete activities that must follow GxPs. These vendors include, but are not limited to, contract research organizations, clinical investigators, manufacturers of drug substance and drug product used in clinical studies and commercialized, labelers and distributors, testing laboratories, warehouses, and so on.
Why You Should Attend:
In order to ensure selection of vendors who are appropriate to complete the job, companies must have in place a robust program for qualifying vendors, contracting with them, managing and overseeing their activities, and a program for mitigating against risks that may arise related to key vendors.
This webinar will address approaches to selecting vendors to perform manufacturing and testing activities as well as clinical study activities. The information obtained will enable implementation of an effective vendor selection program and a comprehensive vendor management and oversight program. The webinar will address aspects of requesting bids, performing audits, evaluating risks, and preparing plans and agreements for effective oversight and management.
- Making a request for proposal to vendors
- Step-by-step considerations for finding potential vendors
- Performing evaluations of vendors
- Implementing a robust qualification & selection process
- Auditing potential vendors
- Strategies for oversight and management of vendors
- Evaluating business continuity of vendors for long-term relationships
- Establishing comprehensive quality agreements
- Risk mitigation approach for key vendors
- Strategy for development of communication plans and oversight activity reviews
- Documenting and monitoring vendor activities
- Value of evaluating back-up vendors
- Quality Assurance Departments
- Quality Control Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Regulatory Affairs Departments
- Validation Personnel
- Clinical Operations Staff
- Project Management Teams
- Non-clinical Study Personnel