Course "Good Laboratory Practice Regulations - Introduction and Strategies for Implementation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
This course will present the regulations and guidelines that apply to the safety testing of medical products and also discuss the rules as they apply to testing laboratories that study samples derived from test animals or test subjects in clinical studies.
The purpose of the course will be to instruct laboratory personnel in the material that they must know or prepare to pass an FDA inspection. The course will also discuss the types of studies that come under the GLP regulations.
Who Will Benefit:
- Lead workers in Product Development
- Regulatory Affairs
- Quality Assurance and Quality Control
- Workers who will be participating in operations or the supervision of the development of new drugs or devices will benefit from knowing what regulations apply to non-clinical studies.
- Workers in animal care facilities and laboratories that operate under GLP regulations should become familiar with the regulations that apply to their work.
Why you should attend:
Any pharmaceutical worker who performs, supervises or reviews non-clinical studies related to product safety should attend this course.
This includes workers who perform studies on samples derived from animals or clinical subjects and anyone performing, supervising or reviewing non-clinical safety studies on any type of product that is regulated by the U.S. Food and Drug Administration. Regulatory Affairs workers who prepare submissions for regulatory agencies also need to be aware of these regulations and their requirements, as they are needed for regulatory submissions.