FDANEWS WEBINAR ON MEDICAL DEVICE QUALITY AUDITS: A “HOW-TO GUIDE” FOR MEETING THE FDA’S 820.22 EXPECTATIONS
This FDANEWS webinar will guide you through setting up best practices and SOPs that will ensure your compliance with FDA record keeping requirements, and ease inspections. All attendees will receive 1.5 hours of RCR Credit.
| What |
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|---|---|
| When |
Jan 13, 2011 from 01:30 pm to 03:00 pm |
| Where | HSC: K-wing, room 2035 |
| Contact Name | Elizabeth Langston |
| Contact Phone | 852-1637 |
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Detail provided by FDANEWS:
FDANEWS WEBINAR ON MEDICAL DEVICE QUALITY AUDITS: A “HOW-TO GUIDE” FOR MEETING THE FDA’S 820.22 EXPECTATIONS
Thursday, January 13, 2011, 1:30 p.m. - 3:00 p.m. on HSC, in the K-wing bldg, room 2035.
This FDANEWS webinar features David Chesney, Vice President of Strategic Compliance Services, PAREXEL; and Peter D. Smith, Vice President for Pharmaceutical Compliance, PAREXEL; both of whom have been conducting FDA investigations for many years. They will guide you through setting up best practices and SOPs that will ensure your compliance with FDA record keeping requirements, and ease inspections.
According to the FDANews website, topics to be covered include:
- How to create unique naming conventions to handle masses of data
- How to prioritize data that might be requested during an inspection
- Pinpoint searching and how to do it
- Developing assessments to gauge the risk of not being able to find a document
- The “Top 10” questions to ask about your archival process
- What to do when documents are not in the general archives
- When emails do count as documentations
- How to explain missing documents to investigators
- If source data is electronic, how to provide access to the regulatory authority
- If source data is paper that was scanned, what to do with the originals
- Tips for dealing with more than one “original”
See website for further details: http://www.fdanews.com/conference/detail?eventId=2988
Seating is limited, so email Elizabeth, or call 859-1637, today to register.
All attendees will receive 1.5 hours of RCR Credit.
