Virtual | Virtual

Event Title

CDER Compliance Conference

January 14, 2021

Date:: January 14, 2021

Visit the CDER Small Business and Industry Assistance Webpage

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)