If you want an opportunity to learn more about how a company prepares for packaging and labeling a clinical supply by walking through each step in the process and actually packaging and labeling a double blind clinical supply, this is the program for you!
Instructors with over 40 years combined Clinical Supply experience!
Maureen Spataro, Spataro & Associates, Inc.
William Chapleau, R.Ph., Clinical Systems, Inc.
Who should attend?
Clinical Supply Project Managers, Coordinators, and Planners
Sales and Business Development Personnel
Clinical Supply Packaging Operators
Clinical Supply Supervisors
Quality Assurance/Quality Control Personnel
Clinical Research Associates
Clinical Research Project Managers
Others interested in learning how to prepare for and package a clinical supply/investigational product.
Learning Objectives: At the conclusion of this program, you will be able to:
Explain the purpose of a clinical trial protocol and how the protocol is used by clinical supply project managers.
Describe and demonstrate how to interpret a clinical trial protocol to determine the treatment regimen and requirements for packaging and labeling the clinical supplies.
Prepare a packaging plan and list the tasks and milestones with approximate timelines for each activity or step necessary to prepare for clinical supply packaging and labeling.
Determine the packaging requirements and calculate quantities of drug product, packaging components, and labels needed for packaging a clinical supply.
Compare and contrast the types of labels used on clinical supplies and be able to explain the elements of the label.
Identify the regulations that apply to clinical supply operations and the conduct of clinical trials.
Define the most commonly used terms used in clinical research and clinical supply operations.
Explain the batch documentation required during packaging operations.
Instructional Approach:
Interactive small group sessions to reinforce learnings, network, and share best practices.
Participant hands-on packaging and labeling of a mock clinical supply.
Ample time for Q & A
Register now: Individual Rate: $1495; Discounts for multiple registrants from the same company. (2 persons: $2795)
