Organizing Data and Document Archives - Webinar CD/Transcript

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Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

Six words not to utter on FDA inspection day:

‘Now, where is that darn document?’

Paper documents unscanned. Naming conventions that don’t make sense. Emails as documentations. Poor communication with the vendors that generate your data. Non-functional (or non-existent) SOPs. Documents missing altogether. Yes, data retrieval is in a sorry state at far too many drug, device, biologics and diagnostics companies.

But your next inspection day need not become scavenger hunt day. Create effective new SOPs for electronic document management, or improve existing ones. It’s easy — when you know how.

Leading GCP/GLP/GMP consultant David Chesney will help you get control of your data. In 90 minutes you’ll learn the basics of developing best practices and SOPs that turn inspection nightmares into routine management tasks. Here’s just a taste of what you and your staff will discover:

  • 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”
  • And lots more besides!

This course will benefit:

  • QA/QC managers and staff
  • Document managers and staff
  • Regulatory affairs managers and staff
  • IT managers and staff

David Chesney, Vice President and Practice Lead, Strategic Compliance Services for PAREXEL Consulting, Prior to joining PAREXEL Consulting in 1995; David served 23 years with the FDA. Between 1972 and 1988 Mr. Chesney advanced from Investigator to Supervisory Investigator and Director, Investigations Branch, working in the Boston, Seattle and Philadelphia District Offices. In 1991, he was appointed as the District Director, FDA San Francisco District Office, where he served until joining the consulting firm of Kemper-Masterson, Inc. (KMI), which was later acquired by PAREXEL. Since 1995, Mr. Chesney has provided compliance consulting and training services to clients worldwide. He presently heads PAREXEL’s Strategic Compliance Consulting group, providing “GXP” compliance services to the pharmaceutical, medical device and biotechnology industries, and the Food and Drug legal community.