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Virtual

Event Title
CDER Compliance Conference
January 14, 2021


Date:
January 14, 2021
Time:
9:00 AM - 3:30 PM ET

 

Presentation Title

FDA Presenter

Compounding: Cleanrooms and Cleanroom Behaviors: Why they Matter

 

Djamila Harouaka, PhD
Microbiologist
Division of Drug Quality III | Office of Manufacturing Quality | Office of Compliance | CDER

Enhanced Drug Distribution Security – Drug Supply Chain Security Act (DSCSA) Implementation Updates

 

Connie T. Jung, RPh, PhD
Senior Advisor for Policy
Office of Drug Security | Integrity and Response | CDER

A Glance at Drug Importation Requirements

 

LCDR Cristina Dar
Imports Team Lead
Office Drug Security, Integrity and Response | CDER

Risk Evaluation and Mitigation Strategies (REMS) Compliance Program

 

Haley Seymour, MS
Consumer Safety Officer
Division of Enforcement and Postmarketing Safety | Office of Scientific Investigations | Office of Compliance | CDER

 

Agenda Slides

In SBIA’s first conference dedicated to compliance, participants will learn from FDA subject matter experts on a range of drug compliance topics including compounding in cleanrooms, drug importation requirements, drug supply chain security act implementation, and Risk Evaluation and Mitigation Strategies (REMS) compliance. Presenters will discuss questions from the audience after each presentation.

TOPICS

  • Compounding: Cleanrooms and cleanroom behaviors: why they matter
  • Drug importation requirements
  • Risk Evaluation and Mitigation Strategies (REMS) compliance program
  • Drug Supply Chain Security Act implementation (DSCSA) implementation updates

INTENDED AUDIENCE

  • Importers and exporters of pharmaceutical products
  • Regulatory affairs work on REMS
  • Outsourcing facilities
  • Boards of Pharmacy
  • Compounders
  • Pharmacists
  • Drug distribution supply chain

 


Event Materials

Title File Type/Size
Agenda_Compliance2021_pdf pdf (103.82 KB)
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