US FDA Requirements for Medical Products Labeling / UDI

Medical device and pharmaceutical manufacturers must incorporate in their quality assurance (QA) program several elements that relate to labeling in order to meet the Good Manufacturing Practice (GMP) requirements of the law (21 CFR XXX. The QA program must be adequate to ensure that labeling meets the GMP products master record requirements with respect to content, legibility, placement,adhesion, etc., and ensure that labeling operations are controlled so that correct labeling is always issued and used. Labeling includes equipment labels, control labels, package labels, directions for use, maintenance manuals, etc. The displays on CRT's and other electronic message panels are also considered labeling if instructions, prompts, cautions, and parameter identification information are given. And recent UDI / GUDID requirements add another level of requirements.

The U.S. Food and Drug Administration (FDA) develops and administers labeling regulations under authority granted by laws passed by Congress that apply to food, drugs, cosmetics, biologics, radiation-emitting electronic products, and medical devices. What are the regulatory requirements? The "must have" elements from the various regulations and guidances for labeling of medical devices and Pharmaceuticals, and the recent UDI / GUDID requirements. Also what constitutes labeling as defined by the FDA.

Participants will learn the basic labeling requirements for medical products, as well as specific requirements for each category of product.
Issues to be covered include:

• Medical devices
• IDEs
• Pharmaceuticals
• Dietary supplements
• OTC products
• General Requirements; Misbranding
• Specific Requirements for each product category
• The UDI / GUDID

This webinar will provide valuable assistance to all regulated companies that need to review and modify their labeling and/or labeling procedures. It will address general as well as specific requirements of medical devices, pharmaceutical, diagnostic, and biologics / human tissue fields. The employees who will benefit include:

• Senior management
• R&D
• Quality Assurance / Regulatory Affairs
• Production
• Engineering, including Product and Manufacturing
• Marketing and Sales, Document Control

Instructor Profile:

John E Lincoln

Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years’ experience in U.S. FDA-regulated industries, 22 as a full-time consultant. 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 published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.