| FDA Roundtable |
| In addition to the quality-focused sessions, Expandability 2010 will feature a special FDA Roundtable session where Expandable customers who operate under FDA guidelines can gather to discuss ideas and techniques for handling challenges associated with regulatory requirements. |
| Key Expandable personnel and software validation experts will be on hand to help drive the discussion and offer perspective on how the Expandable system helps address regulatory challenges. |
| Discussion will include regulatory expectations, their impact on Expandable customers operating under FDA guidelines and solutions Expandable’s products deliver in addressing GMP, getting through validation and FDA audits. |
| The FDA Roundtable is scheduled for the afternoon of Monday May 17 starting at 2PM. The session is open-ended so that participants can spend as much time as necessary Monday afternoon to discuss issues, challenges and solutions. |
| Expandable will initiate the session with an overview of the following areas: |
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FDA 21 CFR Part 820 |
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Subchapter H Medical Devices – Quality System Regulation |
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FDA 21 CFR Part 211 |
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Subchapter C Drugs: General – Current Good Manufacturing Practice for Finished Pharmaceuticals |
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FDA 21 CFR Part 803 |
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Medical Device Reporting: Electronic Submission (eMDR) |
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FDA 21 CFR Part 11 |
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Electronic Records, Electronic Signatures |
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