Falls Church, VA (PRWEB) October 16, 2014
One Unique Device Identification (UDI) deadline has come and gone. Other deadlines loom in the coming months. Don’t risk a 483, warning letter or unhappy customers.
The first UDI deadline for Class 3 device just took effect. The deadline for implantable, life-supporting and life-sustaining devices is rapidly approaching. Device and diagnostics firms must comply or pay the penalty.
But implementation is no walk in the park. It’s not sufficient to master the 160-page final rule. Manufacturers need to be on top of every new FDA guidance. They need to assign responsibilities, set schedules and deadlines, and establish audit and quality procedures.
Come to Chicago Nov. 11 or Boston Nov. 13 for a crash course in UDI, taught by a seasoned expert in medical device and diagnostics compliance issues.
Attendees will start the morning with a deep dive into what UDI and GUDID are, how they apply to products and services and take part in the first exercise of the day, reviewing cases to determine when a change requires a new device identifier.
Then it’s on to the nuts and bolts of device, label and package UDI. This session covers compliance dates, direct marking, device labeling, package configurations and more, winding up with two exercises reviewing cases to determine compliance date, and hands-on application of package configuration rules.
After lunch and networking, it’s on to the GUDID including how to populate it, how to maintain it, and technical aspects of data loading. Attendees finish up by actually developing GUDID data for one of their own devices.
The day concludes with an in-depth look at updating the QMS including the regulation itself, medical device reports, corrections and removals, record retention, FDA inspections, 510(k)s and eMDRs.
The included course materials enhance the workshop’s value:
- Label and package implementation checklist
- Package configuration worksheet
- Excel worksheet that implements the GUDID business rules
The first UDI compliance deadline has come and gone. The next deadline will be here soon. Make sure the manufacturer is in full compliance and warning letter-proof.
Meet the Instructor:
Dan O’Leary has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. Mr. O’Leary is President of Ombu Enterprises, LLC a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies.
Who Should Attend:
- Regulatory Managers
- Design Engineers
- Labeling Specialists
- Project Managers
- Quality Managers
- Quality Engineers
- Executive management
- R&D staff
- Strategic planning staff
It Won’t Wait Until You Are Ready
**Presented by FDAnews and Ombu Enterprises**
Nov. 11, 2014 – Chicago, IL
Nov. 13, 2014 – Waltham, MA
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.