Clinical Supplies “Foundations” Course
This course is for clinical supplies folks who are new to the industry. The goal of this course is to provide the foundational knowledge of the clinical supply chain and how it fits into drug development.
Our goal is to provide a high-energy interactive and practical training program that helps create, or fill in, foundational knowledge about the clinical supply chain from beginning to end.
Application of the course concepts will be achieved through presentations, workshops, case studies, life experiences, and lively interaction between the instructors and participants.
Upon completion of the course, each participant will be able to explain the Clinical Supply Chain, where they fit into it, how their role is essential, and how it interacts with other departments, companies and stakeholders. Once they learn this, when they return to their jobs, they will be able to perform at a higher, and more effective level.
Our ultimate objective is to have each of our attendees return to their organizations with the knowledge, skills and drive to be an even greater asset to your team.
Course Content Includes:
1. Introduction to Clinical Supplies and the cGMPs
2. Phases of New Drug Development and Approval
3. The Clinical Supplies Life Cycle
4. Quality Assurance, Risk Based Management & Change Control
5. Production Records and Forms
6. Blinding Drug & Randomization Concepts
7. Protocol Interpretation
8. Developing, Writing & Controlling SOPs
9. Clinical Trial Material (CTM) Labeling
10. Patient and Site Compliant Packaging
11. Stability and How it Generates Expiry/Retest Dating
12. Material Control & Warehousing
13. Returned Drug Accountability
14. Good Distribution Practices (GDPs)
15. Global Regulatory Changes Impacting CTMs (Includes the EU Clinical Trial Regulation impacts and adjustments)
Who Should Attend this Course:
Our Foundations Course is designed to build a solid foundational understanding of Clinical Supplies, and/or fill in gaps for:
Clinical Supplies Operations
Clinical Supplies Supervisors and Managers
Quality Assurance & Quality Control Associates
New Business Development People
Clinical Research Associates
Regulatory Affairs Professionals
Administrative Support Staff
Others involved with the Clinical Supply Chain