Effectively Managing Vendor Oversight - Online Academy
It is essential for industry to employ efficient and accurate strategies for monitoring outsourced clinical trials to minimise the chances of receiving warning letters from competent authorities. Companies should have robust structures in place for successful vendor selection, contract design, quality monitoring and risk minimisation when outsourcing clinical trials to remain compliant.
Using a combination of theory and practical examples, this essential 10-module course will provide a crucial overview of your responsibilities as a sponsor, giving you the knowledge you need to ensure quality oversight over 5 weeks.
Suitability - Who should attend?
All professionals who are involved in vendor oversight will benefit from this course, including:
- Clinical Outsourcing
- Contracts and Outsourcing
- Clinical Quality Assurance
- Clinical Quality Control
- Clinical Operations
- Vendor Management
- Global QA/Compliance
- Regulatory Affairs
Training Course Content
Course Content Summary
- Module 1: Introduction to outsourcing
- Module 2: Meeting regulatory expectations
- Module 3: Selection of the right outsourcing partners
- Module 4: Vendor management
- Module 5: Vendor oversight
- Module 6: What is governance? Implementing an effective governance structure
- Module 7: Risk management for clinical outsourcing
- Module 8: Maintaining health business relationships
- Module 9: Using metrics effectively when outsourcing
- Module 10: High level legal and financial considerations when outsourcing
- Introduction to the complexities of vendor selection, management and oversight
- Review of different outsourcing strategies and models
- Different outsourcing models from strategy, through vendor selection and effective implementation
- Comprehend your responsibilities as the sponsor both from GCP perspective and from vendor management perspective
- Identify the right level of management and oversight
- Understand the outsourcing strategies for selecting, monitoring and communicating with your service providers
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
85% had applied content during the course to their role
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PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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