Why Should You Attend:
This program will discuss practical development of packaging design and optimizing the design to fit the intended purpose. Participants will learn how to translate a protocol into optimal package design. A review of the compliance requirements between commercial and clinical packaging and labeling will be completed. The course will review a case study of changing commercial packaging for optimization.The program will also review how to establish an effective artwork change management and approval system, including real-life examples of system successes and potential pitfalls.
Areas Covered in the Webinar:
- Commercial packaging and labeling compliance (required text; prohibited text; format and layout requirements for various types of packaging and labeling; filing and approval requirements)
- Design change control (change control review and approval process; requirements for agency approval; SOP for process; reviewing, tracking and reporting design changes)
- Clinical packaging and labeling development and compliance (required text; format and layout requirements; considerations for blinding and global clinical trial requirements)
Who Will Benefit:
- Manufacturing personnel
- Quality and compliance personnel
- Regulatory personnel
- Clinical operations
Course Provider

Peggy Berry,


