www.hhs.gov U.S. Department of Health and Human Services
Activity Outline
What to Expect after an Inspection: 483s, Responses and Beyond
December 14, 2022


Activity Coordinators:
Brenda Stodart (brenda.stodart@fda.hhs.gov),  Forest Ford (forest.ford@fda.hhs.gov)
Description

During this webinar, FDA will provide an overview of what to expect after an inspection. FDA will discuss the FDA Form 483, inspection closeout, post-inspection expectations and regulatory responses.


References
  • https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-form-483-frequently-asked-questions
  • Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry
  • FDA https://www.fda.gov/regulatory-information/search-fda-guidance-documents/contract-manufacturing-arrangements-drugs-quality-agreements-guidance-industry
  • Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry
  • FDA https://www.fda.gov/regulatory-information/search-fda-guidance-documents/current-good-manufacturing-practice-guidance-human-drug-compounding-outsourcing-facilities-under
  • Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice
  • FDA https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sterile-drug-products-produced-aseptic-processing-current-good-manufacturing-practice
  • Human Drug Compounding - https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding
  • Compounding Quality Center of Excellence
  • Training Programs https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence-training-programs
Learning Objectives
  • Evaluate FDA's post-inspection expectations
  • Construct action plans and submit responses pursuant to FDA Form 483 observations
Target Audience
This activity is intended for physicians, pharmacists, nurses, and Pharmaceutical Industry.
Agenda
Day 1 December 14, 2022
Time Topic Speaker
2:00 - 3:00 PM EST What to Expect after an Inspection: 483s, Responses and Beyond JENNIFER DELVALLEORTIZ
REBECCA ASENTE, M.S., R.D.
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 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-22-080-L03-P for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 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.
Disclosure

Faculty
  • ASENTE, REBECCA, M.S., R.D., Compliance Officer, U.S. FDA - nothing to disclose
  • DELVALLEORTIZ, JENNIFER, Supervisory Consumer Safety Officer, Food and Drug Administration - nothing to disclose

Planning Committee
  • Brodsky, Eric, MD, Associate Director, FDA/CDER/OND/Labeling Policy Team - nothing to disclose
  • Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose
  • Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose

CE Consultation and Accreditation Team
  • Darlise Henderson, MBA, Training Specialist,FDA/CDER/OEP/DLOD - nothing to disclose
  • Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.
Registration Fee and Refunds
Registration is complimentary, therefore refunds are not applicable.
Requirements for Certificate of Completion (Non CE)
There are no imposed requirements.
ACCME Joint Accreditation
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