Packaging and Labeling for Commercial and Clinical Products 2016

Topics

• Design change control (change control review and approval process; requirements for agency approval; SOP for process; reviewing, tracking and reporting design changes)
• Commercial packaging and labeling compliance (required text; prohibited text; format and layout requirements for various types of packaging and labeling; filing and approval requirements)
• Clinical packaging and labeling development and compliance (required text; format and layout requirements; considerations for blinding and global clinical trial requirements)

Who should Attend

Attendees from:

• Manufacturing Personnel
• Who can Benefit
• Regulatory Personnel
• Quality and Compliance Personnel
• Packaging Technology
• Clinical Operations
• Package Engineers
• Labeling Coordination
• Regulatory Affairs
• Packaging Operations
• Quality Assurance Consultants
• Sales and Marketing