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Visit CDER Small Business and Industry Assistance Page

 

ABOUT THIS WEBINAR

During this webinar, FDA will provide an overview of what to expect after a compounding inspection. FDA will discuss the intent of an FDA Form 483, ‘Inspectional Observation,’ compounding inspection closeout meetings, post-inspection expectations and regulatory responses, and provide a few examples to help explain how best to respond to an FDA Form 483 observation after a compounding inspection.

If an FDA investigator observes potential violations of the Food Drug and Cosmetic (FD&C) Act and its implementing regulations during an inspection, then an FDA Form 483 is issued to the most responsible person at a firm at the conclusion of the inspection. The FDA Form 483 does not constitute a final agency determination and firms are encouraged to respond to the FDA Form 483 in writing with their corrective action plan with supporting documentation within 15 business days from the issuance of the FDA Form 483 and implement the corrective action plan expeditiously.

 

TOPICS COVERED

• FDA Form 483
• Compounding Inspection Closeout Meetings
• FDA Form 483 Responses for Compounding Inspections
• Post-Inspection Expectations
• FDA Form 483 Examples and Regulatory Responses for Compounding Inspections

 

INTENDED AUDIENCE

• Compounding Outsourcing Facilities
• Compounding pharmacies with interest in the outsourcing facility sector and FDA compounding inspections
• State pharmacy regulators
• Consultants focused on outsourcing facilities and compounding pharmacies
• FDA-regulated industry or general public with an interest in the inspections process for compounding pharmacies and outsourcing facilities

 

FDA SPEAKERS

Jennifer DelValleOrtiz, MS
Supervisory Consumer Safety Officer
Division of Compounding I (DC1)
Office of Compounding Quality & Compliance (OCQC)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER) | US FDA

Rebecca Asente, MS, RD
Compliance Officer
Office of Pharmaceutical Quality Operations (OPQO)
Office of Regulatory Affairs (ORA) | US FDA

 

FDA RESOURCES

• FDA Form 483 Frequently Asked Questions
• Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry
• Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry
• Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice | FDA
• Human Drug Compounding
• Compounding Quality Center of Excellence | Training Programs
• FDA Inspections of Outsourcing Facilities (webinar)
• Compounding: Cleanrooms and Cleanroom Behaviors: Why they Matter (webinar)

 

CONTINUING EDUCATION

This webinar has been approved for 1.00 contact hour of continuing education for physicians, pharmacists, and nurses. Please see detailed announcement for more information. After the course concludes, that day's attendees will receive an email with instructions and a code to claim their credit. Only participants who attend the live broadcast via Adobe Connect will receive the claim code.

This webinar has been:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion
• 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.
• pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

 

TECHNICAL INFORMATION

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• Please contact [email protected] for all technical questions.
• If you encounter any technical issues before or during the event, please visit the Technical Issues Support
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