Organizing Data and Document Archives - Webinar Recording/Transcript

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

Are your documents as organized as you think they are? Can you easily put your hands on the documents FDA investigators request? Or are you searching for that needle in a haystack?

Paper documents unscanned. Naming conventions that don’t make sense. Emails as GXP documentation. 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.

FDAnews has invited a leading GXP (GCP/GLP/GMP) consultant to help you get control of your data. In 90 fast-paced minutes you’ll learn the basics of developing best practices and SOPs that turn inspection nightmares into routine management tasks.

Presentation Takeaways:

  • The legal basis of FDA records access authority including what FDA has NO access to
  • Types of documents commonly requested during inspections
  • Problems and pitfalls to avoid
  • The Top 10 questions to ask about your archival process
  • What to do when documents are not in the general archives
  • The perils of emails as GXP documentation — and how to avoid them
  • If source data is electronic, how to provide access to the regulatory authority
  • True copies versus originals — what is deemed acceptable under GXP regulations?
  • The impact of the shift to real time electronic review of documents during inspections

Don’t go searching for the needle in a haystack on inspection day.

  • Auditors or others who host regulatory inspections
  • QA/QC managers and staff
  • Document managers and staff
  • Regulatory affairs managers and staff
  • IT managers and staff

David L. Chesney, MSJ, is the Principal and General Manager for DL Chesney Consulting, LLC, providing GMP and GCP compliance consulting and training services to clients worldwide. He served for over 20 years as Vice President, Strategic Compliance Services for PAREXEL Consulting. Prior to joining PAREXEL Consulting, he served 23 years with the FDA, serving as an Investigator, Supervisory Investigator, Director of Investigations and ultimately as District Director in San Francisco, managing all FDA operations in Northern California, Nevada and Hawaii. He also served as an Evidence Development instructor for FDA at the national level.

Mr. Chesney has a Bachelor's degree in Biology from California State University, Northridge, plus three years of graduate study in Biology at CSU Northridge and CSU San Diego, and an MS in Jurisprudence, concentrating in Pharmaceutical and Medical Device Law from Seton Hall University School of Law. Mr. Chesney is a member of PDA, where he serves on the faculty of the Training and Research Institute. He is also an active member of the Food and Drug Law Institute and RAPS.