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cGMP Compliance Series: Analytical Instrument Qualification (AIQ) Best Practices for the Nutraceutical / Dietary Supplement IndustrycGMP Compliance Series: Analytical Instrument Qualification (AIQ) Best Practices for the Nutraceutical / Dietary Supplement Industry
October 1, 2013
2 Min Read
The FDA requires, under 21 CFR Part 111, that manufacturers of dietary supplements must calibrate or qualify laboratory instrumentation associated with the manufacture, testing, or release of a dietary supplement. We will cover and highlight the content in the valuable guidance document, USP <1058>: Analytical Instrument Qualification (AIQ). In addition, a portion of the presentation will be devoted to emerging best practices. At the conclusion of this presentation the audience should know what needs to be done on a practical level to qualify or calibrate their laboratory instrumentation and how to document such activities to successfully pass an audit.
Our discussion will focus on FDA Regulations and USP accepted standards of instrument qualification. Specifically, we will focus on:
21 CFR Part 111: cGMP in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
USP <1058>: Analytical Instrument Qualification (AIQ)
Session Objectives:
After completion of the Webinar, participants will have a good understanding of:
The FDA regulations regarding Instrument Qualification/Calibration, and the industry accepted qualification practices
When instrument qualification is necessary and which lab equipment requires qualification or calibration
How to construct, execute, and document an audit proof instrument qualification package
Evolving best practices A Universal Approach
Speaker:
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