FDAnews Announces — FDA Required Internal cGMP Audits: Using Innovative Risk-Based Techniques to Revitalize Your Program Webinar, Dec. 10, 2014

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Just because the last FDA/ISO inspection was passed, don’t be lulled into complacency. 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, and offer tips for properly documenting and presenting the results when the inspector knocks.

FDA Required Internal cGMP Audits:
Using Innovative Risk-Based Techniques to Revitalize Your Program
**FDAnews Webinar**
Dec. 10, 2014 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/RequiredInternalCGMPAudits

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 an 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 the last FDA/ISO inspection was passed, 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 Relying on outdated procedures is dangerous.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.

Attendees will 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 that the manufacturer is “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!

Meet the Presenter:
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.

Who Will Benefit:

  •     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

Webinar Details:
FDA Required Internal cGMP Audits:
Using Innovative Risk-Based Techniques to Revitalize Your Program
**FDAnews Webinar**
Dec. 10, 2014 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/RequiredInternalCGMPAudits

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/RequiredInternalCGMPAudits
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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