Summary:
Sigmatech provided Instructional Design, Course development and implementation for content provided by the FDA. The courses were hosted both on Sigmatech Systems and on FDA’s LMS.
Services Provided:
- Bad Ad Recognition and Reporting
- Chemistry, Manufacturing and Controls
- Human Drug Establishment and Drug Listing Compliance
- Engaging with the FDA During New Drug Development
- Generic Drug User Fee Act (GDUFA)
- FDA State Tobacco Compliance Check Inspection Program
- Best Practices for Communication Between FDA and IND Sponsors During Drug Development