Packaging and Labeling for Commercial and Clinical Products
Duration: 90 Minutes
This training program will discuss optimizing your packaging design for commercial and clinical products and translating a protocol into effective packaging design. Attendees will learn how to implement an effective artwork change management system. Real-life case studies and dos/don’ts for packaging and labeling for commercial and clinical products will also be discussed.
Objectives of the Presentation
Why Should you Attend
- 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)
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.
Who can Benefit
- Manufacturing Personnel
- Quality and Compliance Personnel
- Regulatory Personnel
- Clinical Operations
- Packaging Technology
- Labeling Coordination
- Package Engineers
- Packaging Operations
- Regulatory Affairs
- Sales and Marketing
- Quality Assurance Consultants