Long-term Preservation of Records Needed for Drug Regulatory Compliance

Why Should You Attend:

There are retention requirements for records that are used in support of requests to market and sell drugs in various countries. Depending on the country, these retention periods can be 30 years or more.

At some future time, because of some unforeseen drug reaction, the FDA may request you to produce records that were created 25 years ago. The first issue is locating where these records are, and if found, can the contents be viewed using current computer hardware and software. Perhaps the media is virtually extinct or the original authoring software cannot be interpreted.

This webinar will discuss strategies you can follow to minimize the chances that these things will not occur. The presenter will outline strategies and processes that are being followed by most governmental archives, international models and standards, and show how you can implement them at your organization.

Areas Covered in the Seminar:

• Record validity and security.
• Regulatory & legal requirements for electronic records.
• Media options.
• Software formats.
• International models & standards.
• Strategies for short and long term archiving.