CDER Compliance Conference
January 14, 2021
Webcast
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.
- Drug Supply Chain Security Act (DSCSA) https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa
- FDA Risk Evaluation and Mitigation Strategies
- REMS https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems
- List 5 cleanroom best practices.
- Explain REMS and how they are created.
- Describe FDA import requirements.
This activity is intended for physicians, pharmacists, and nurses.
Day 1 January 14, 2021
Time | Topic | Speaker |
---|---|---|
9:00 - 9:15 AM EST | Overview | Brenda Stodart, PharmD, MS, BCGP, RAC |
9:15 - 9:25 AM EST | Keynote | DONALD ASHLEY, JD |
9:25 - 10:25 AM EST | Compounding: Cleanrooms and Cleanroom Behaviors: Why they Matter | Djamila Harouaka, PhD |
10:25 - 10:45 AM EST | Break | |
10:45 - 11:45 AM EST | Enhanced Drug Distribution Security – Drug Supply Chain Security Act (DSCSA) Implementation Updates | Connie Jung, PhD, R. Ph |
11:45 - 1:00 PM EST | Lunch Break | Not offered for CE |
1:00 - 2:00 PM EST | A Glance at Drug Importation Requirements | Cristina Dar |
2:00 - 2:20 PM EST | Break | |
2:20 - 3:20 PM EST | Risk Evaluation and Mitigation Strategies (REMS) Compliance Program | Haley Seymour, MS |
Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.
Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Faculty
- ASHLEY, DONALD, JD, Director Office of Compliance, FDA - nothing to disclose
- Dar, Cristina, Senior Science Health Advisor, HHS-FDA-CDRH-OCD - nothing to disclose
- Harouaka, Djamila, PhD, Senior Scientific Advisor, CDER/OPQ/OQS - nothing to disclose
- Jung, Connie, PhD, R. Ph, Senior Advisor for Policy, FDA/CDER/Office of Compliance - nothing to disclose
- Seymour, Haley, MS, Consumer Safety Officer, Food and Drug Administration - nothing to disclose
- Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
Planning Committee
- Kleppinger, Cynthia, MD, Medical Officer, FDA - nothing to disclose
- Navin, Lesley, RN, MSN, Consumer Safety Officer, FDA/CDER/DDI - nothing to disclose
- Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
CE Consultation and Accreditation Team
- Bryant, Traci, M.A.T., CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
- Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Registration is complimentary; therefore refunds are not applicable.
Must attend 90% of the activity.