Clinical Trial Materials
Applying Production, QA, and Packaging Processes

Upcoming Dates and Locations

Date Location Country Instructor(s) This course is not currently scheduled, but may be conducted on-site. Please contact ISPE Customer Service.

Description

So much is involved in the all-too-important process of clinical trial materials (CTM) operations. In this course, you will receive a thorough overview of the manufacture of bulk finished products for clinical supplies, including protocol review, packaging and labeling requirements and issues, outsourcing, and CTM regulatory requirements. The course will also cover production requirements for bulk finished products, package design, study requirements, and CTM product labeling and packaging. Participants will compare the manufacture of bulk drug products for clinical supplies with that of commercial production, and discuss dosage form design, industry terminology, the regulatory process, and current Good Manufacturing Practices (cGMPs) and how they relate to CTM. The course will also cover general laboratory information such as calibration, documentation, and standard operating procedure requirements; the basics of project planning; outsourcing practices; and other issues in the CTM area.

A complimentary copy of the Comprehensive Guide to Clinical Materials will be provided to each participant. 

This course contains knowledge related to the CPIP™ technical knowledge competency element Facilities and Equipment. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ispe-pcc.org.

Take Back to Your Job 

• Define requirements for clinical products in terms of active pharmaceutical ingredients (APIs), formulation, manufacturing, and packaging and labeling of CTM
• Explain documentation, cGMPs, and regulatory needs
• Compare manufacture of clinical supplies to marketed products
• Describe outsourcing and project planning as they apply to clinical products
• Identify the roles of the clinical manufacturing and packaging units and how they interact with clinical research and the clinic
• Demonstrate how to translate a CTM protocol to packaging design and needs

Attendance Suggested For

• Pharmaceutical professionals new to the CTM area who are involved in the manufacture, review, packaging and labeling of clinical trial materials
• Note to Clinical Supply Chain Managers and Supervisors: This is an excellent way to document general training for employees in the areas of cGMPs and CTM operations

Continuing Education Units

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be mailed within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.