September 24-25 in San Diego, CA
Hosted by Q1 Productions
enLabel Global Services is the proud Gold Sponsor and Keynote Speaker for this event. Topics to be addressed include: Clarifying UDI Requirements & First Lessons Learned In Industry Compliance, Optimizing Label Translation & Content Localization Strategies all while Streamlining Label Approval Operations & Minimizing Human Errors.
With the large variety of device and diagnostics on the market, and the ongoing development of new products every year, patients and healthcare professionals need to clearly understand how to handle and utilize medical products safely. This crucial information is conveyed through labels and instructions for use that must respond to an increasing number of complex rules. Labels also serve to enable health authorities, manufacturers and professionals to track products throughout the entire product life-cycle. Ultimately, enhanced traceability facilitates timely post-market surveillance and product recalls, as well as assists in the fight against global medical product counterfeiting. With the release of the FDA UDI rule in 2013, device and diagnostic corporations have had to overcome the challenge of developing new strategies to include this feature in labels, along with implementing the technology that UDI involves. While certain classes of products have reached UDI compliance dates, others are still in the process of building internal processes.
An area of ongoing challenge for labeling executives is also the management of efficient, timely and cost-friendly translation projects. Labels must comprise up to 36 languages, and standards in medical terminology, label content and delivery means differ greatly from one country to another.
A large number of teams within the corporation are involved in the development and collection of critical information that will be utilized to create the label and IfU, Each team involved must have a perfect understanding of the impact of an error in this sensitive data, and internal label approval processes are often lengthy and tedious to ensure no human error is overseen. Furthermore, device and diagnostic labeling and regulatory teams are continuously looking for means of enhancing label compliance strategies in order to ensure the high standards set by health regulators in the United States as well as in international markets are met. Labels must comprise a large number of data and it is of the utmost importance that differing international requirements are perfectly understood to ensure compliance.
As in all Q1 conferences, speakers from the industry, standard organizations and regulatory bodies will provide timely insight on topics impacting labeling operations through engaging presentations and interactive sessions.
With labeling executives actively looking for new technology and solutions for streamlining labeling programs, sponsors will find this conference to be a perfect business development opportunity.
Practical insight into the first lessons learned from the industry with UDI
Review & ongoing clarification of challenging areas in the FDA UDI rule
- Latest developments in the MDR-IVDR and forecasting the impact on labeling
- Optimizing regulatory labeling strategies to incorporate international labeling updates
- Addressing the inclusion of customs data into labels & international trade compliance
- Development of time and cost-effective translation strategies for global labels
- Enhancing electronic instructions for use distribution outside of the US
- Workshop: perspectives in building a label from the ground-up
- Labeling requirements & evolving regulations in expanding marketplaces
- Best practices in minimizing human error in labels & instructions for use
- Practical insight & strategies in single source publishing & XML formatting
- Clarifying the need for CMS & the impact on labeling
- Label verification auditing best practices
- Developing a global regulatory strategy: how to ensure efficiency
- Label regulatory approval & proof-reading best practices
- Selecting & testing label substrates pertinent to the medical product
- Streamlining, optimizing & expediting internal labeling approval processes