Recalls, Failure Modes, and Deficiencies of Drug Products

NIPTE Mini Course

Registration is now closed. Please subscribe to be on our list when the next session is scheduled.

Course dates: October 28 – November 22, 2019

Course Outcomes

Upon completion of this mini-course the student will be able to compare historical incidents and root causes of recalls, failures and deficiencies of drug products and develop an awareness of how to anticipate/prevent such incidents at the design stage.

About this Course

This 4-week, case-study based mini-course will be taught online by FDA scientists, former FDA directors, and professors with extensive experience identifying and solving problems related to recalls, failure modes, and deficiencies. The course will conclude with a real-time online summary session. Special emphasis is placed on:

  • Linking API solid state characteristics and liabilities on dosage form quality; and,
  • Risk assessment
    • Incidents involving pharmaceutical solids and crystallization, including Ritonavir
    • Incidents involving solid state transformations
    • Complex dosage forms
    • FDA perspective

This free offering is provided as introduction to the NIPTE Pharmaceutical Science & Technology Certification Program – an online educational offering designed to advance working professionals’ understanding of the ways drug products are designed, developed and manufactured with emphasis on safety and scientific rationale. Students who complete the multicourse program will be certified in the broad areas of pharmaceutics, formulation, industrial pharmacy, and solid state chemistry.