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  4. CDER Compliance Conference - 01/14/2021 - 01/14/2021
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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

Agenda

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

FDA SPEAKERS

Donald D. Ashley

Director

Office of Compliance (OC) | CDER

Djamila Harouaka, PhD

Microbiologist

Division of Drug Quality III | Office of Manufacturing Quality | Office of Compliance | CDER

Connie T. Jung, RPh, PhD

Senior Advisor for Policy

Office of Drug Security | Integrity and Response | CDER

LCDR Cristina Dar

Imports Team Lead

Office Drug Security, Integrity and Response | CDER

Haley Seymour, MS

Consumer Safety Officer

Division of Enforcement and Postmarketing Safety | Office of Scientific Investigations | Office of Compliance | CDER

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance. Certificates are only available during the three weeks post-event. This course:

  • has been pre-approved by RAPS as eligible for up to 8 credits towards a participant’s RAC recertification upon full completion.
  • has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

QUESTIONS

Please contact info@sbiaevents.com for all technical questions.

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Event Materials

Title File Type/Size
Agenda_Compliance2021_pdf pdf (103.82 KB)
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