FDA Labeling and UDI Essentials for Medical Products

Understanding and complying with the U.S. FDA's stringent requirements for medical product labeling is crucial for manufacturers in the medical device and pharmaceutical industries. The FDA mandates comprehensive labeling standards under 21 CFR 801 to ensure the safety, efficacy, and quality of medical products.

Medical device and pharmaceutical manufacturers must incorporate specific elements related to labeling into their quality assurance (QA) programs to meet Good Manufacturing Practice (GMP) standards. This involves ensuring that labeling meets the requirements of the product's master record concerning content, legibility, placement, and adhesion. Additionally, labeling operations must be controlled to guarantee that the correct labeling is always used. Labeling encompasses equipment labels, control labels, package labels, directions for use, maintenance manuals, and even electronic displays that provide instructions, prompts, cautions, or parameter identifications. Recent Unique Device Identification (UDI) and Global Unique Device Identification Database (GUDID) requirements add further layers of compliance.

WHY YOU SHOULD ATTEND:

The FDA develops and enforces labeling regulations under the authority granted by laws enacted by Congress. These regulations apply to food, drugs, cosmetics, biologics, radiation-emitting electronic products, and medical devices. This webinar will cover the essential elements from various regulations and guidance documents pertinent to the labeling of medical devices and pharmaceuticals, including the latest UDI/GUDID mandates.

Participants will learn the basic labeling requirements for medical products and the specific requirements for different categories of products. Key topics covered include labeling requirements for medical devices, Investigational Device Exemptions (IDEs), pharmaceuticals, dietary supplements, and over-the-counter (OTC) products. The webinar will address general requirements, issues of misbranding, and specific criteria for each product category, ensuring participants are well-equipped to meet FDA standards.

AREAS COVERED IN THE SESSION:

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

WHO SHOULD ATTEND:

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 from these department will benefit most:

• Quality Assurance Departments
• Research and Development Departments
• Regulatory Affairs Departments
• Production Departments
• Engineering Departments
• Manufacturing Departments
• Document Control Specialists

Course Director: José Mora 

José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment. José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under José’’s leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.