Long-term Preservation of Records Needed for Drug Regulatory Compliance
Tuesday, November 13, 2012 from 10:00 AM to 11:15 AM (PST)
Palo Alto, CA
This webinar will cover strategies for short and long term archiving of records that are 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.
Date: November 13, 2012
Time: 10:00 AM-11:15 AM PDT
Cost: $249 per attendee per computer terminal
Registration: SIgn-Up on-line now. Add to your shopping cart.
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.