RQAP re-registration units: 4 GLP, non-GCP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units
DescriptionThis course is a comprehensive introduction to FDA Good Laboratory Practice regulations or refresher training for all personnel involved in a nonclinical laboratory study. The course also provides a review of GLP history, examination of the FDA Preambles, offers topical comparisons between FDA and EPA requirements and OECD Principles, and is intended to equip the participant with a working knowledge of GLP impacts on study conduct. Opportunities for group interaction and breakout periods help widen the educational exchange while enhancing the learning process.
ObjectivesAt the end of the course, the participants shall be able to:
- Understand the regulatory requirements for nonclinical laboratory facilities, equipment, personnel, methods, practices, records and controls to assure Management of compliance or report the lack thereof
- Identify compliance gaps in the overall quality system of a facility and suggest improvements based upon regulatory requirements
- Effectively communicate the requirements of FDA GLPs and identify topical differences between FDA and EPA requirements and OECD Principles of GLP
- Interpret and apply GLP requirements using a variety of resources
- Use the knowledge obtained by completing the training exercises to increase effectiveness in current role
Target AudienceThis course is a comprehensive introduction to FDA Good Laboratory Practice regulations or refresher training for all personnel involved in a nonclinical laboratory study.
Agenda- Basic GLP Training Overview
- Landmark Cases in the Development of GLP
- Organization of the GLP Regulations
- Scope and Definitions
- Contracting Under GLPs and Inspections of Testing Facilities
- Organization and Personnel
- Facilities
- Equipment
- Testing Facilities Operation
- Test and Control Articles
- The Protocol
- Conduct of Nonclinical Laboratory Studies
- Reporting of a Nonclinical Laboratory Study
- Storage, Retrieval, and Retention
- Electronic Record Keeping in Nonclinical Laboratory Studies
- Shall vs. Should
- FDA/EPA Regulations vs. OECD Principles of GLP