Security Labeling/E-Pedigree

For many years the agencies and regulated industry worldwide have been concerned with tracking and tracing of Pharmaceutical products not only for potential recalls but for the prevention of counterfeit products. Some methods can be very costly to use but others have been found to provide the results, simple to implement and can be very cost affective. Last year the FDA revised their compliance date and has now established 2011 as the year for developing and implementing a method to not only comply with their requirements but for individual states in the U.S. that will be passing legislation to enact E-Pedigree.

Learn what you can do right now to make this happen without waiting until 2011 to look for an answer. Now find the answers to get you started in reducing your risks in making changes to your products and improve the time to get those important changes implemented.

Areas Covered in the seminar:

• What are my options now and in the future to meet E-Pedigree and Security Labeling requirements and which one fits my application? :
  • What security applications are there and what meets my needs and budget?
  • What are the risks and costs associated with counterfeit products?
  • How easy is it to counterfeit products and what products have the highest risk?
  • What do I need to consider before I select the type of technology?
  • What are the keys to making it work?
  • What controls do I need in my operation?
  • What will the FDA be looking for?

Who will benefit:

The webinar provides information on the FDA's focus on the need for security packaging and how to prepare to be ready when the 2011compliance date arrives. Those that will benefit most by the training include:

• Regulatory Affairs Personnel
• Quality Assurance Associates
• Product Managers
• Labeling Coordination
• Legal
• Packaging Operations
• Packaging Technology 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.

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