FDA Required Internal cGMP Audits - Webinar CD/Transcript
FDA Required Internal cGMP Audits: Using Innovative Risk-Based Techniques to Revitalize Your Program
Sec. 820.22 of the QSR requires devicemakers conduct annual internal audits of a company’s quality systems. They need to be independently conducted, include re-audits of problem areas, are thoroughly documented and reviewed by senior management.
Pharma, biologic and dietary supplement companies don’t have a specific internal audit requirement, but Sec. 211.180 (e) and (f) requires annual review of quality records by senior management. Plus, ICH Q7 infers internal audits are necessary.
The number of 483s and warning letters that cite failures to conduct these internal audits are on the rise.
Here’s a proven way to revitalize your internal audit program…
In just 90 minutes, audit expert John Lincoln will show how to boost company-wide awareness of internal audit requirements and best ways to conduct the audits themselves — plus tips for properly documenting and presenting the results when the inspector knocks.
Just because you passed your last FDA/ISO inspection, don’t be lulled into complacency. Regulators are getting tougher. Relying on outdated procedures is dangerous. Stay on the good side of the regulators. Be up to speed on latest techniques.
- Why the FDA and other regulators require internal audits — underlying issues that make audits a necessity
- How to be proactive: Getting buy-in, from middle management on up to the C-level bosses
- A proven risk-based, phased approach that ensures key internal aspects are properly audited and documented
- Saving scarce resources: Tips and best practices to cut audit time and expense
- Documenting the audit: How to prove to regulators you are “in control”
- Avoiding internal-audit “entropy”: Don’t fall back on a past year’s audit. Here’s now to make sure each year’s audit is robust and effective.
- And much more!