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.
Inspections for Outsourcing Facilities	Overview of the inspection process for compounding outsourcing facilities and discusses what to expect during an inspection, from initiation to closeout as well as observations on successes and challenges.
What to Expect after an Inspection: 483s, Responses and Beyond	Overview of what to expect after a compounding inspection. FDA discusses the intent of a Form FDA 483, inspection observations, inspection closeout, post-inspection expectations and regulatory responses and provides a few examples to help explain how best to respond to a Form FDA 483 observation.
Regulatory Framework for Human Drug Compounding (52min 12sec)	Overview of the human drug compounding regulatory framework, including differentiating drug compounding from FDA new drug approval process and the agency’s bulk drug substance evaluation process.
Environmental Monitoring in Compounding (1h 22min 55sec)	An overview of environmental monitoring for compounding facilities and the role environmental monitoring plays in ensuring product quality and patient safety. FDA discusses the statutory and regulatory requirements for environmental monitoring, our expectations for compounders (under section 503A of the FD&C Act) and outsourcing facilities (under section 503B) for environmental monitoring and different methods specific to environmental monitoring.