Compounding Quality Center of Excellence | Recorded Webinars
The FDA Compounding Quality Center of Excellence offers free recorded webinars to provide information about current good manufacturing practice standards and the agency’s inspectional processes.
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Topic |
Description |
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Highlights why cleanrooms and cleanroom behaviors are important for preventing insanitary conditions that can adversely impact the quality and safety of drugs. |
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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. |
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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. |
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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. |