Clinical Supplies: The Basics and Beyond
Join us for an exciting five-day online course which will focus on the fundamentals and select advanced topics of the clinical supplies process.
The course covers both US and EU perspectives.
Our goal is to have each person return to their organization with the skills and enthusiasm to be a more confident and productive team member.
The management of clinical trial materials is a complex, specialized skillset. Our instructor has extensive experience managing large, international trials. Our clinical supplies training focuses on best practices for clinical supplies from both GCP and GMP perspectives, and covers both US and EU expectations, and will help your team remain current with the latest industry and regulatory trends.
INSTRUCTOR
Greg Kushla, Executive Director of Jeiven Pharmaceutical Consulting, Inc.
Greg brings more than 20 years of research and Clinical Supplies experience to the course. Prior to joining JPC, Greg was Sr. Director, Clinical Supply Operations for Daiichi Sankyo. He has held pharmaceutical R&D management positions at Abbott Laboratories (formerly Knoll Pharmaceutical) and Parke-Davis. Greg brings his strong knowledge of Clinical Supplies, GMPs, and FDA regulations to our clients through his consulting, training and auditing. Greg received his degrees from Rutgers University.
Refund/Cancellation Policy
We understand that sometimes due to unforeseen circumstances people are unable to attend a course they have registered for. Please click here to see our course refund page and to see our policies regarding course cancellation.
Register Today
Clinical Supplies: The Basics & Beyond Topics
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Introduction to Clinical Supplies and cGMPs
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Phases of New Drug Development and the Drug Approval Process
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Clinical Supplies Life Cycle
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Quality Assurance and Change Control
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Good Documentation Practices and Production Records
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Developing, Writing, and Controlling SOPs
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Blinding and Randomization Concepts
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Clinical Protocol Interpretation
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Packaging and Labeling Clinical Trial Material
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Patient and Site Compliant Packaging and Labeling
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Stability and How it Generates Expiry/Retest Dating
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Material Control and Warehousing
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Shipping and Distribution – including Good Distribution Practices
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Returned Drug Accountability
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QP Responsibilities Including Certifications and Declarations
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Clinical Trial Directive
THIS COURSE CAN BE CUSTOMIZED AND OFFERED ON-SITE AT YOUR COMPANY. CONTACT US FOR MORE INFORMATION.