Packaging and Labeling for Commercial and Clinical Products
Duration : 90 Minutes
Peggy J Berry,
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, Read more
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.
Course Objective:
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.
Course Outline:
• Laws and regulations related to packaging and labeling
• Guidelines implemented during clinical, commercial packaging and labeling
• Implementing SOPs to ensure compliance
• Implementing appropriate change control procedures
• Selection of materials for packaging and labeling
• Required submission content for the IND/NDA related to packaging and labeling materials and procedures
• Clinical packaging compliance
• Clinical labeling compliance
• Commercial packaging compliance
• Commercial labeling compliance
• Change control for materials, design and content
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Manufacturing personnel
• Quality and compliance personnel
• Regulatory personnel
• Clinical operations
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
