Test Article Management and Characterization for Drugs and Devices

Why Should You Attend:

The presentation will begin with a review of GLP requirements for test and control article characterization, regardless of whether the article is a drug or device. It will address the study director's responsibilities and sponsor responsibilities in test article characterization. Attendees will learn the best practices for managing GMP characterizations, stability, and certificates of analysis. Special attention is given to the testing that must be performed to show that no test material carried over into control materials. Carryover has become one of FDA’s target areas in recent years because of the serious effect it has on drug safety results. The presentation treats carryover as a special topic in test article/control article characterization. The presenter also emphasizes the importance of control article characterization.

The presentation then covers the unique aspects of medical device characterization and stability testing. This discussion describes how device design planning and development fit into characterization. The webinar also covers combination products, how to identify what makes up the test article, and then the testing to show stability and characterization. This section is followed by a discussion of stability testing in general as it applies to characterization.

The presentation will conclude with recommendations of how labs can improve their test article management from feasibility studies to archiving. The webinar provides information on test article chain-of-custody, distribution, handling and storage, usage, and archiving. Special mention is given to devices that have been recovered from a test system and returned to a lab for post-study evaluation. The webinar concludes with a list of main points or take-home messages regarding characterization. It includes passages from warning letters in which labs failed to fully characterize the test article before beginning a study or which describe related compliance issues.

Areas Covered in the Seminar:

• What are the recommended procedures for chemical and physical characterization of drugs/devices in safety testing.
• What are the basic requirements of test article characterization.
• How to manage carry-over from test to control article
• How to use GMP test article characterization and the certificate of analysis for a GLP study
• How to define a device test article
• How to characterizing medical devices
• Stability testing for drugs and devices
• How to document test article usage and distribution

Who Will Benefit:

This webinar is for sponsors, study directors, and other GLP study participants with responsibility for test article characterization

• Study directors
• Management at sponsor companies
• Principal investigators
• Laboratory staff
• Contract laboratories
• Device manufacturers

Instructor Profile:

Anne Maczulak, PhD, RQAP-GLP, is an independent consultant at Acorn GLP Consulting. She has more than 20 years experience as sponsor, study director, or participating scientist in preclinical studies. Anne works with established companies, startups, and universities in need of guidance in GLP regulations. She has presented webinars for FDA and training courses for the Society of Quality Assurance. She audits laboratories that conduct nonclinical studies and/or bioanalysis and provides on-site as well as remote training in GLP.

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