The definition of labels is well defined and ususally well known; "labeling" not so well. Differing requirements for different applications can be confusing and are the subject of this webinar.
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.,
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 means to comply with each category of requirement.Areas Covered in the Webinar:
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:
Principal, J E Lincoln and Associates
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. John 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 software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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