Current Job and Project Opportunities

Posting: #FDAAA 17-023
Job/Opportunity: Opportunity to Lecture to Regulators on ICH Q1
Organization: CBER

FDA is assisting in organizing an ICH training program on ICH Q1 Stability and is seeking FDA Alumni experts (more than one speaker) interested in lecturing. The training is to be held at Northeastern University (NEU) in Boston, MA October 11-13. Travel may be covered by NEU. Topics include:

  • Why stability tests are needed
  • Monitoring stability throughout the life cycle
  • Methods to ensure stability under market conditions and environmental conditions
  • Data package for climatic zones III and IV (Q1F/WHO)
  • New drug substance and products (Q1A)
  • Stability of Biotechnology products (Q5C)
  • New Dosage forms (Q1C)
  • Photostability (Q1B)
  • Bracketing and Mixing (Q1D) and other topics

If you are interested or have questions, please contact Michelle Limoli of CBER at michelle.limoli@fda.hhs.gov or phone 301-796-8377.

Posting Date: 09/17