Quality Auditing for Added Value and Continuous Improvement



Oh no! The auditor is coming this week! Whether it is the FDA or an important customer or the Corporate Compliance Group, even pre-announced visits by these outside auditors can induce strain, apprehension and/or outright fear in many individuals. It doesn’t need to be this way.
When performing an audit, it doesn’t take much experience to come up with a list of things that could or should have been done or done differently, t’s that should have been crossed and i’s that should have been dotted. These auditors only look for compliance to satisfy any ISO and regulatory requirements. However, they often leave the auditee with a long list of things to correct, some at significant cost or effort, which may not decrease risk or contribute to real improvement in the bottom line. As a result, internal auditors can be frustrated because their findings are either ignored for more important projects or only result in more work for themselves when they are assigned to fix the problems they discovered.

Rather than citing multiple, and often trivial non-conformances, organizations that effectively use their internal audit programs are able to proactively identify any compliance issues as well as significant improvements to save millions of dollars. These auditors are considered heroes, and those to be audited actually look forward to their visits.

Over time, inefficiencies and waste creep into every process, either as a result of previous audits or as unintended consequences of other “improvement” initiatives. These inefficiencies are not identified in a typical compliance-only audit, as long as the activity itself satisfies the standard or regulatory requirements.

This presentation will cover basic auditing principles to enhance your own internal audit program to add real value to the organization. Emphasis is placed on realizing system interactions and the cultural environment that often prevents improvement.

Areas to be Covered:

Basic overview of auditing (types of audits, auditor qualifications, audit process)
Seeing how the organizational environment encourages problems
Changes in audit philosophy
Auditing as a benchmarking tool
Audit reporting techniques to get management attention
Audit Program metrics to drive performance improvement and add value

Who will Benefit:

This webinar will benefit any organization / association / audience that wants to improve the effectiveness of their internal audit program. Participants should have some previous experience with quality auditing, but otherwise, this talk is applicable to all levels as it covers underlying principles in a simplified format. The staff who will benifit form this webinar are:
QA Managers
Manufacturing Managers
QA Engineers
Manufacturing Engineers
Quality System Auditors
Executives and Managers responsible for reviewing audit results and taking action

Antony J. DeMarinis

Tony DeMarinis has BS degrees in Biology & Microbiology and a MS in Quality Management. He is currently an independent Consultant specializing in Sterilization, Quality Systems, Auditing, and other Quality Management issues in the medical device and pharmaceutical industries. Previously, Tony was Director of QA/RA at Tunstall Americas for electronic monitoring devices, Quality Manager at Sealed Air for medical packaging, Quality Systems Manager at Davol for implants and surgical devices, Director of Quality Assurance at Scott Laboratories for in-vitro diagnostics and Sr. Microbiologist at the National Cancer Institute.

He is recognized as a Fellow by the American Society for Quality, and he is a Certified Quality Auditor, BioMedical Auditor, Six Sigma Black Belt, Pharmaceutical GMP Professional and Manager for Quality and Organizational Excellence. He also teaches the refresher courses for the CQA and CMQ/OE certification programs through the local ASQ sections. Tony has over 25 years’ experience using quality management techniques and value added auditing including the use of Failure Investigation and Root Cause Analysis to improve processes and products.


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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance