The definition of labels is well-defined and usually well-known; "labeling" not so well. Differing requirements for different applications can be confusing and are the subject of this webinar.
Why Should You Attend
Labels and Labeling. Label for various types of products or types of submissions. All can be confusing. The FDA looks very carefully at labeling during both device submission 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 scrutiny 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.
Add to this the UDI/GUDID requirements, and also court decisions that marketing is labeling. Confusing? This webinar will break these requirements down into the basics and examine the means to comply with each category of requirement.
Webinar Takeaway
- Label vs. Labeling
- Basic CGMPs and Labeling
- Submission categories of labeling.
- Specifically required controls.
- On product, on carton, on shipper labels; IFUs
- Shipper labels - their differences
- UDI (and GUDID)
- Product category differentiation
- Marketing and "labeling".
1.5 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 3 credits towards a participant's RAC rec
Speakers
John E. Lincoln,
Principal Consultant ,
J. E. Lincoln and Associates LLCJohn E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company, with over 33 years’ experience in U.S. FDA-regulated industries and 20 years as a full-time consultant. He has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.
He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process/ product/ equipment including QMS and so+E6ftware validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CGMP subjects. He is a graduate of UCLA.
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:
- Senior management
- Regulatory Affairs
- Quality Assurance
- Production
- Engineering
- Sales and Marketing
