FDA Labeling And UDI Essentials For Medical Products
🎤 José Mora ‎ | 📅 Recording Available | 🕒 90 Minutes
  | 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. |
Description:
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.
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
