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 doesn’t need to become a scavenger hunt. 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.
- The legal basis of FDA records access authority, including what FDA can’t access
- 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.
Who Will Benefit:
- 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