Labels and Labeling. Label for various typeds of products or types of submissions. All can be confusing. The FDA looks very carefully at labeling during both device submissions reviews as well as CGMP compliance audits. Problems in label composition, application, and also in their control, handling, issuance, and reconciliation can get a company quickly in trouble. Review the basics of labels/labeling, and see the various areas of application in this webinar, including some little known or controlled areas which are subject to regulatory scruinty by both the FDA, and even a competitor trying to `level the playing field` with their competition.
FDA medical device labeling requirements are found in several CFRs, i.e.
General Device Labeling - 21 CFR Part 801;
Use of Symbols - 21 CFR Part 801.15;
In Vitro Diagnostic Products - 21 CFR Part 809;
Investigational Device Exemptions - 21 CFR Part 812;
Unique Device Identification - 21CFR Part 830;
Good Manufacturing Practices - 21 CFR Part 820;
General Electronic Products - 21 CFR Part 1010.
Agenda
Label vs. Labeling
Basic CGMPs and Labeling
Submission categories of labeling.
Specific required controls.
On product, on carton, on shipper labels; IFUs
Shipper labels - their differences
UDI (and GUDID)
Product category differentiation
Marketing and `labeling`.
Who Should Attend
This webinar will provide valuable assistance to all regulated medical device companies that need to review and ensure their labels/labeling meet current US FDA requirements. The employees who will benefit include:
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