What to Expect after an Inspection: 483s, Responses and Beyond
December 14, 2022
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.
- 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
- Evaluate FDA's post-inspection expectations
- Construct action plans and submit responses pursuant to FDA Form 483 observations
This activity is intended for physicians, pharmacists, nurses, and Pharmaceutical Industry.
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. |
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
- 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
- Henderson, Darlise, MBA, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
- Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
All relevant financial relationships have been mitigated.
Registration is complimentary; therefore refunds are not applicable.
There are no imposed requirements.