Compounding Quality Center of Excellence | Recorded Webinars
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The FDA Compounding Quality Center of Excellence offers free recorded webinars to provide information on current good manufacturing practice standards, inspections and policies.
Recorded Webinars
| Topic | Description |
|---|---|
| Cleanrooms and Cleanroom Behaviors: Why they Matter (1h 7min 53sec) | Highlights why cleanrooms and cleanroom behaviors are important for preventing insanitary conditions that can adversely impact the quality and safety of drugs. |
| Regulatory Framework for Human Drug Compounding (52min 12sec) | Covers the human drug compounding regulatory framework, including differentiating drug compounding from FDA drug approval process and the agency’s bulk drug substance evaluation process. |
| Environmental Monitoring in Compounding (1h 22min 55sec) | Examines environmental monitoring for compounding facilities and the role environmental monitoring plays in ensuring drug quality and patient safety. Highlights the statutory and regulatory requirements for environmental monitoring, the agency’s expectations for compounders and different methods for environmental monitoring. |
| FDA Inspections of Outsourcing Facilities (56min 8sec) | Provides an overview of the inspection process for outsourcing facilities from the initiation to the closeout. Includes the challenges outsourcing facilities face during inspection. |
| What to Expect after an Inspection: 483s, Responses and Beyond (1hr 1min 5sec) | Describes what to expect following an FDA inspection. Discusses the inspection closeout; form 483, which outlines the FDA investigator’s inspection observations; the agency’s post-inspections expectations; as well as explains how a compounder can best respond to a form 483. |