Compliance Packaging/Labeling Requirements Overview

We all know that we need a package that will deliver, protect and be compatible with our Pharmaceutical products. We also need to have a label that meets the labeling requirements for our products with the FDA but that is only part of it. What does the FDA really mean when they say that we must have a package and labeling that is compliant? The FDA uses terms such as appropriate, adequate, timely and periodically but what does that really mean? We must have a package and labeling for our products that not only meets our standards but also meets the consumer needs and the agency needs.

To meet these challenges it is important that we have a clear understanding of what it takes in a package and our labeling needs and requirements. We will cover a little more than just what the basics are in get into the details of what it takes to have Compliant Packaging and Labeling.

Areas Covered in the seminar:

• What does Compliance Packaging and Labeling really mean?
• Your products need to be compatible with your packaging and your packaging compatible with your products but how do we know?
• How do I select the best method for delivery of my product and is that the package?
• What do I need to consider if there is a need to change my packaging?
• When the FDA says labeling what does that include?
• What are my options when the FDA keeps wanting more information in our labeling.
• Overview of Structured Product Labeling (SPL)and Physicians Labeling Rule (PLR).

Who will benefit:

Over the years we have learned much about what it takes to have good packaging and labeling for our products but one failure in this area can be very costly to our companies. In order to insure that we stay up to date on the direction that our compliance packaging and labeling is going the following would benefit from this webinar:

• Packaging Technology
• Labeling Coordination
• Package Engineers
• Packaging Operations
• Regulatory Affairs
• Sales and Marketing
• Quality Assurance Consultants

Instructor Profile:
James E. Ingram, CPP, FM, is the President of INGRAM Consulting Services and has over 30 years experience in Manufacturing and Packaging of Pharmaceutical, Food and Cosmetic products. Over 16 years of his career has been spent in management of compliance processes 11 of which were with GlaxoSmithKline where he was the Manager of North American Change Control. During this time Jim was the Point Person for insuring that all documents and data were available for audits and inspections. Over the past 7 years Jim has provided consulting services in all areas of compliance processes including custom training programs.