If you are a Sponsor or Laboratory employee involved with any part of a non-clinical study for a drug, device or food ingredient, you need to be aware of what the FDA expects from you or your data may not be considered in the application.
For any course taught at your facility, additional modules may be added. We also offer them as stand-alone modules.
These modules include:
Preparing for an FDA Audit
How to select Contract Laboratories (Contract Research Organizations, CROs)
Study Director GLP Training
GLP Training for the Animal Care Professional
GLP Training for Metrology and Equipment Monitors
GLP Training for Sample Handling
Standard Operating Procedure (SOP) Preparation and Review
GLP Requirements for Management and Sponsors
Nonclinical (Preclinical) Testing
Food Additive Safety Testing (Redbook)
Food Additive Petition (FAP)
Pharmaceutical Nonclinical Development Process
Investigational New Drug (IND)
New Drug Application (NDA)
Common Technical Document (CTD)
Contact us at 847-295-9250 or rcg@robinguy.com for additional information.