A UL course
Get an introduction to regulations and guidelines that oversee the process of laboratory sample collection and shipping human specimens for clinical research use in the United States.
Participants will learn:
- To identify the rules and regulations that apply to laboratory samples
- To recognize how a sponsor uses the services of a central laboratory
- How a principal investigator utilizes a local laboratory
- How to identify the sponsor and investigator site responsibilities for collection of specimen
- How to package and ship a specimen
Compliance resources to ensure that sponsors and investigator sites maintain compliance with mandatory regulations will be provided.
- Clinical laboratories
- Clinical Laboratory Improvement Amendments (CLIA) certification
- Sponsor role
- Site responsibility and documentation
- Medical waste disposal
- Packaging and transport of specimens
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields