FACT: Labeling and Packaging mix-ups and errors are still one of the major sources of product recalls.  Labeling mix-ups remained in FDA's list of top 10 reasons for product recalls in 2004.

QUESTION: What do changing the measurements of a leaflet, switching to a different ink and using cheaper type of glue all have in common?

ANSWER: They all result in your packaging coming UNSTUCK!!
Cartons that open in transport spilling or breaking product; Labels that detach during cold storage; Ink smudges when it passes through the machine; Packaging machine stops every few seconds because the leaflets move and it reads a wrong bar-code;
These are just a few examples of the damage that can be caused when the purchasing department decides to switch to a new printer to "save money."

Course Objective: The goal of the course is to provide participants with an understanding of the inherent dangers and complexity of handling, managing and controlling printed packaging materials so as to minimize the likelihood of inaccuracies in text, of mix-up of versions and  / or of product recall because of packaging or labeling mix-ups.

At the completion of this course the participant will be able to:

• Perform an initial assessment of a printer for willingness and ability to meet their company's cGMP needs
• Prepare / define quality elements of an SOP for work at the printer
• Audit a printer for cGMP compliance
• Understand the warehouse design requirements and ongoing controls needed for printed packaging materials
• Understand the dangers inherent in packaging operations and be able to address them with solutions for minimizing their potential effect on company products
• Manage versions of printed packaging materials

• 21 cfr Subpart G – Packaging and Labeling Control: US cGMP requirements
• EC requirements for packaging and labeling controls
• Controlling content and artwork of printed packaging materials including version control and cataloging materials
• Auditing and approval of printers of packaging materials
• SOP for GMP at the print shop
• SOP for approval of a new printer
• SOP for change control of printed packaging materials
• The dangers in changing printer – penny-wise / pound-foolish
• Receipt, counting, sampling and testing printed packaging materials and reconciliation of printed packaging materials on receipt and during use
• Storage of printed packaging materials
• Issuing printed packaging materials to production, preparation of batch specific quantities / series of batches / reconciliation and what happens if the batch is not manufactured (returning materials to warehouse inventory)
• Use of printed packaging materials:  Opening a packaging line in production; reconciliation at end of use and returns to the warehouse

WHAT YOU WILL LEARN:  This course will provide participants with tools for managing printed packaging materials in accordance with regulatory requirements and so as to minimize the chance of a product mix-up or recall arising from the wrong label / package or patient leaflet.  The course will provide valuable insight into quality issues regarding printed packaging materials and their management for persons in product management and marketing as well as those in the logistics department.