Who Should Attend
This two-day course is designed for those who perform, supervise, manage, audit, or oversee the creation, approval, control and regulatory affairs involved with labels and labelling. This includes, but is not limited to, professionals in Design Controls, Quality Control, Quality Assurance, Process Controls and Regulatory Affairs. The course will also benefit those process owners who are involved with meeting the customer’s requirements, i.e. the end-user and the FDA.
Upon completion of this course, attendees will have a working understanding of regulatory agency expectations and will have gained the background knowledge necessary to effectively establish and implement label controls and the ramifications of inaccurate labeling.
Participants will gain practical experience from real-time examples, and an interactive foundation for benchmarking and cross-functional discussions. Because a segment of the session will be dedicated to recall (because of labeling issues) this course will enable participants to realize how risk management affects and establishes labeling decision-making from concept and feasibility and (then) throughout the lifespan of the device.
This course provides comprehensive and up-to-date knowledge of labeling development and subsequent control. The course covers regulatory expectations regarding labeling requirements in the FD and C Act, the Fair Packaging and Labeling Act, labeling for investigational devices, label control in the cGMP-QSRs and Part 801 (general controls).
This course will address labeling in terms of the following