Labeling and Labeling Controls
All medical device firms develop and provide labeling for their products and customers. Labeling must be prepared in accordance with applicable regulations principally described in 21 CFR 801. The process of acquiring and controlling labeling that is provided on or in conjunction with products distributed by a firm is managed under the requirements of 21 CFR 820. In addition, there are special labeling requirements for certain types of products in both guidance documents and related regulations.
To address the industry’s need for ongoing education on labeling and labeling controls, AAMI offers this webinar cd. Program content is focused on applying the principles described in the FDA regulations related to labeling guidance: The webinar:
- Discusses what is included in the term labeling
- Provides a brief summary of the labeling requirements
- Discusses understanding what is included in labeling
- Focuses on practical application of the labeling guidance and industry best practices
- Covers electronic labeling: what’s new
| Introduction - Brief overview of labeling relations | ||
| Key labeling terms | ||
Primary Requirements |
||
| Overview of principle labeling regulations | ||
| Control of labeling in manufacturing | ||
| Discussion of which aspects of supplier controls come into play for the scenario | ||
| Special labeling requirements (in vitro diagnostics) | ||
| E-labeling | ||
| Interactive ideas/ Q&A from audience | ||
| Summary and wrap-up | ||
SPEAKERS
- Arthur J. Ward, PhD, Medical Device Consultant, AJW Technology Consultants Inc.
- Christine Nelson, Trainer/Consultant
WHO WOULD BE INTERESTED...
The webinar is designed for quality management, production, labeling design, and marketing professionals. These individuals may represent medical device manufacturers, consulting businesses, FDA, and other organizations that require information on effective implementation of labeling control and management methods used to meet regulatory requirements such as FDA's Quality System regulations.
WEBINAR CD
- Includes pdf of handout materials and webinar recording on CD.
- Please note that the CD will be available three weeks after the program.
- $295 for webinar registrants
- $395 for non-registrants
THREE WAYS TO PURCHASE
- Phone - 1-877-249-8226 or 240-646-7031 to order with a credit card.
- Fax - Select and download the order form and fax to 240-396-5781
- Mail - Select and download the order form and mail with payment to:
Labeling and Labeling Controls CD Package
AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211
Arlington, VA 22201-4795
QUESTIONS?
For
questions about ordering the CD, please contact Publications at 1-877-249-8226 or 240-646-7031.