Clinical Supplies Training
The management of clinical trial materials is a complex, specialized skillset. Our instructors have extensive experience managing large, international trials. Our clinical supplies training focuses on best practices for clinical supplies from both GCP and GMP perspectives, and cover both US and EU expectations. Help your team remain current with the latest industry and regulatory trends.
Clinical Supplies Training is presented at our off-site seminars, but can also be presented on-site at your company.
The training can be customized to meet your company’s specific needs. We can create customized program content for new employees, experienced personnel who need refresher training, or specialized groups such as clinical operations, clinical supplies, regulatory staff, Quality, etc. You can select from our listed topics or we can incorporate other relevant topics that you request. If desired, a half-day workshop beginning with protocol interpretation and carrying through a blinded packaging labeling exercise can be included.
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ADVANCED CLINICAL SUPPLIES TOPICS
- Global Cultural Challenges
- Outsourcing and Vendor Management, including Quality Agreements
- Controlled Temperature Distribution
- Nimble Supply Strategies including JIT, direct-to-patient, site-to-site transfer, and more
- Project Management for Clinical Supply Professionals
- Navigating International Studies including labels, import/export, and more
- IRT in the 21st Century including accountability and returns
- Comparators including sourcing, blinding techniques, and analytical considerations
CLINICAL SUPPLIES: THE BASICS & BEYOND TOPICS
- Introduction to Clinical Supplies and cGMPs
- Phases of New Drug Development and the Drug Approval Process
- Clinical Supplies Life Cycle
- Quality Assurance and Change Control
- Good Documentation Practices and Production Records
- Developing, Writing, and Controlling SOPs
- Blinding and Randomization Concepts
- Clinical Protocol Interpretation
- Packaging and Labeling Clinical Trial Material
- Patient and Site Compliant Packaging and Labeling
- Stability and How it Generates Expiry/Retest Dating
- Material Control and Warehousing
- Shipping and Distribution – including Good Distribution Practices
- Returned Drug Accountability
- QP Responsibilities
- Impact of Clinical Trial Regulations