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| 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)
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| Contact us at 847-295-9250 or rcg@robinguy.com for additional information. |
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