FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes

This training will provide a solid understanding of FDA Requirements for Device Labeling. Attendees will gain comprehensive knowledge on creation, approval and control of labels and labeling.

Who will benefit:

This webinar is designed for those who perform, supervise, manage, audit, or oversee the creation, approval, control of labels and labeling:

• Regulatory Affairs management
• Document Control (label generation) professionals
• Design Control professionals
• Quality Assurance professionals
• Sales/marketing management

Instructor Profile:

Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.