Clinical Supplies Frameworks (Advanced) Course
For experienced professionals ready to master advanced clinical supply chain frameworks. Reserve your seat below.
Discover. Connect. Engage.
Who Should Attend:
Our Frameworks (Advanced) Course is designed for experienced clinical supplies professionals ready to deepen their expertise and close specific gaps, including:
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- Clinical Supplies Operations
- Clinical Supplies Supervisors and Managers
- Quality Assurance & Quality Control Associates
- New Business Development Professionals
- Clinical Research Associates
- Regulatory Affairs Professionals
- Administrative Support Staff
- Others involved with the Clinical Supply Chain
Topics Covered
- Introduction to Clinical Supplies and the cGMPs
- Phases of New Drug Development and Approval
- The Clinical Supplies Life Cycle
- Quality Assurance, Risk Based Management & Change Control
- Good Documentation Practices/Production Records and Forms
- Blinding Drug & Randomization Concepts
- Protocol Interpretation
- Developing, Writing & Controlling SOPs
- Clinical Trial Material (CTM) Labeling
- Clinical Supplies Packaging
- Patient and Site Compliant Packaging
- Stability and How it Generates Expiry/Retest Dating
- Material Control & Warehousing
- Good Distribution Practices (GDPs)
- Returned Drug Accountability
- Global Regulatory Changes Impacting CTMs (Includes the EU Clinical Trial Regulation - Latest Updates)
Event Information
Registration Cost: $1,500
Your course seat is included with CRISP (San Francisco) or NECSO (Waltham) event registration. Hotel and venue details for your selected event are provided in your registration confirmation.
Clinical Supplies Frameworks (Advanced) Course Registration
If you have any questions about your registration please contact:
Christine Riches
Director of Operations
Global BioPharm Solutions, LLC
(M) +1-949-636-3483
christine@mygbsolutions.com