Audio Conference

Meeting FDA Requirements for Structured Product Labeling (updated!) Don Bridges Commercial Tech Docs Manager Data Conversion Laboratory

Register for this Audio Conference

As of October 31, 2005, the FDA requires that all US-marketed package inserts (USPIs) be submitted in XML format. Structured Product Labeling (SPL) and the implications of implementing an XML solution are becoming more obvious. But what are the options? The short-term solution may be very different than the long-term solution. And the 'right answer' may vary for companies of different sizes.

Whether yours is a pharma company scrambling to comply with the new requirements, or a device manufacturer wondering what the future holds for you in terms of SPL, this presentation will focus on the options available to meet the FDA's XML mandate from a vendor-neutral perspective, equipping the attendees with pros and cons for each option so that they can formulate an approach that meets their regulatory and business requirements.

This audio conference will cover:

• Current expectations as relayed by the FDA
• Lessons learned in the SPL implementation process
• The outlook for devices, veterinary and OTC products
• The different types of solutions available
• Pros and cons for each option in terms of risk, cost, schedule, infrastructure impact, etc.
• The impact of PIM (the European standard) on the approach, and what is happening in other parts of the world

About the speaker:

Don Bridges is the commercial tech docs manager at Data Conversion Laboratory (DCL). In this capacity, he works with customers from life sciences, aerospace, manufacturing, transportation, and other industries to help develop a migration plan that meets business and technical requirements. He is a frequent conference speaker and has written several articles on the business aspects of XML implementation. Prior to joining DCL he worked in the engineering, consulting, and software fields. He has a Bachelor's degree in Engineering from LSU and calls Albuquerque, NM home.

Who should attend?

• Regulatory Affairs personnel
• Directors/Managers of Safety
• IT/IS staff
• Documentation managers
• Senior management
• Marketing
  
  This audio conference is classified as General Interest.
  
  

Registration Options

• Purchase a CD recording $US145

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