FDA Required Internal cGMP Audits - Webinar CD/Transcript

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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 Relying on outdated procedures is dangerous.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.

You’ll discover:

  • 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!
  • Senior management in pharmaceuticals, biologics, devices, combination products, dietary supplements, laboratory developed tests
  • QA/QC
  • cGMP internal audit teams
  • Engineering
  • Production
  • Operations
  • Regulatory affairs
  • Consultants

John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consultancy with more than 32 years’ experience working with FDA-regulated industries from Fortune 100 to startups. He specializes in regulatory affairs, QA, QMS problem remediation and FDA responses, new/changed product 510(k)s, process/product/equipment including QMS and software validations, ISO 14971 product risk management files/reports, Design Control/History Files and Technical Files. He has published articles and conducted workshops worldwide on CAPA, 510(k)s, risk analysis/management, GMP audits, validation, root cause analysis and other FDA-related topics.