www.hhs.gov U.S. Department of Health and Human Services
Activity Outline
CDER Compliance Conference
January 14, 2021
Activity Coordinator:
Lisa Misevicz (lisa.misevicz@fda.hhs.gov),  RENEE WILLIAMS (RENEE.WILLIAMS2@FDA.HHS.GOV)

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
Learning Objectives
  • List 5 cleanroom best practices.
  • Explain REMS and how they are created.
  • Describe FDA import requirements.
Target Audience
This activity is intended for physicians, pharmacists, and nurses.
Day 1 January 14, 2021
9:00 - 9:15 AM Overview Brenda Stodart, PharmD, BCGP, RAC-US
9:15 - 9:25 AM Keynote DONALD ASHLEY, JD
9:25 - 10:25 AM Compounding: Cleanrooms and Cleanroom Behaviors: Why they Matter Djamila Harouaka, PhD
10:25 - 10:45 AM Break
10:45 - 11:45 AM Enhanced Drug Distribution Security – Drug Supply Chain Security Act (DSCSA) Implementation Updates Connie Jung
11:45 - 1:00 PM Lunch Break Not offered for CE
1:00 - 2:00 PM A Glance at Drug Importation Requirements Cristina Dar
2:00 - 2:20 PM Break
2:20 - 3:20 PM Risk Evaluation and Mitigation Strategies (REMS) Compliance Program Haley Seymour, MS
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 4.25 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 4.25 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity.
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-21-030-L04-P for 4.25 contact hour(s).
FDA Center for Drug Evaluation and Research designates this activity for 4.25 contact hour(s).
Requirements for Receiving CE Credit

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.

Important Note regarding completion of evaluations and receiving credit
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.

  • 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, Microbiologist, CDER/OC/OMQ/DDQIII nothing to disclose
  • Jung, Connie, 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, BCGP, RAC-US, 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, BCGP, RAC-US, 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 Fee and Refunds
Registration is complimentary, therefore refunds are not applicable.
Requirements for Certificate of Completion (Non CE)
Must attend 90% of the activity.
ACCME Joint Accreditation
  • This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this Government system, which includes (1) this computer network, (2) all computers connected to this network, and (3) all devices and storage media attached to this network or to a computer on this network.
  • This system is provided for Government-authorized use only.
  • Unauthorized or improper use of this system is prohibited and may result in disciplinary action and/or civil and criminal penalties.
  • Personal use of social media and networking sites on this system is limited as to not interfere with official work duties and is subject to monitoring.
  • By using this system, you understand and consent to the following:
    • The Government may monitor, record, and audit your system usage, including usage of personal devices and email systems for official duties or to conduct HHS business. Therefore, you have no reasonable expectation of privacy regarding any communication or data transiting or stored on this system. At any time, and for any lawful Government purpose, the government may monitor, intercept, and search and seize any communication or data transiting or stored on this system.
    • Any communication or data transiting or stored on this system may be disclosed or used for any lawful Government purpose.