This UDI training will highlight the different aspects of FDA's UDI Rule is Coming in 2010 and how it will impact your company. It will also give insight in to UDI alternatives.
On September 27, 2007, the FDA Amendments Act of 2007 was signed into law. This act includes the requirement to establish a Unique Device Identification System or UDI. The purpose is to facilitate the tracking of medical devices in order to minimize counterfeiting as well as facilitate the reporting and tracking of product problems and recalls.
This new system will require:
- The label of a device bears a unique identifier, unless an alternative location is specified by the FDA or unless an exception is made for a particular device or group of devices;
- The unique identifier must be able to identify the device through distribution and use; and
- The unique identifier is to include the lot or serial number of the device, if specified by the FDA. Some alternatives include Bar Codes and RFID.
Draft regulations are being drafted by the FDA for public comment. Attend this UDI training to know What is the purpose of these changes? How will this impact your company and its distribution system? What steps should your company be doing right now to be in compliance. The UDI alternatives, and their pros and cons.
Areas Covered in the seminar:
- The mandate.
- FDA directions.
- The fundamentals of UID.
- Key issues and possible directions.
- Current alternatives: Bar Codes and RFID.
- Don't be caught off-guard, playing expensive "catch up".
Who will benefit:
This webinar will assist all those involved in this medical device "pedigree" system, including: Medical device manufacturers, distribution centers, health care product distributors, doctors, nurses, hospitals, clinics, nursing homes and other health care providers and professionals. These include:
- Senior management
- Regulatory Affairs
- Quality Assurance
- Production
- Engineering
- All personnel involved in the labeling, distribution, storage, tracking, use, failure-investigation, CAPA, and post-production reporting of medical devices.
Instructor Profile:
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 28 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up o 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.
