Through the eyes of an auditor... how your plant looks to an auditor and how you can make the best first impression

Instructor: Jose Mora
Product ID: 700734
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jan-2008

Training CD / USB Drive

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Read Frequently Asked Questions

This webinar will provide valuable assistance to medical device and pharmaceutical companies whose success will often depend on outside auditors.


An experienced auditor does not need to dig very far - he or she already has a mental checklist. You need to know what that is.

An auditor can often tell within the first 30 seconds to 5 minutes how well an audit is going to result. While a fresh set of eyes can help pinpoint potential problems, a better approach would be for the owner of each process and function to know how their area looks to an outside auditor and how to transform their area so that the first impression is consistently a good one and, preferably, so that one never needs to prepare for an audit if one is always prepared.

Areas Covered in the seminar:

  • An external auditor is coming to your plant. Their first impression may have a major impact on your plant’s future as well as your own career. How will your plant look to that auditor?
  • Before they even set foot in the door - what your grounds and outside facility says about your operation.
  • Approaching the production area - tell tale signs that will influence the auditor’s perception.
  • Your cleanroom gowning area - how the audit could be almost over before it has even started.
  • It’s only a utility room - why would they want to look in there?
  • Your janitor’s closet - it might as well be your front porch.
  • Do you follow your own rules? The auditor is noticing this very carefully - and taking notes.
  • Can you "put your hands on it." Documents, procedures, manuals, and reports - why five minutes may be too long to change a first impression.
  • Process and environmental control - quick impressions.

What will Attendees Learn (Key takeaways):

  • An experienced auditor does not need to dig very far - he or she already has a mental checklist. You need to know what that is.
  • The importance of housekeeping, proper maintenance, ordeliness, and following safety rules.
  • The importance of visual indicators - and following them.
  • Utility rooms and custodial closets are often places to hide clutter. Some experienced auditors know that this tells them more about your systems than the clean and presentable areas.
  • How using the same logic as the auditors can help you be in a state of constant readiness.

Who will benefit:

This webinar will provide valuable assistance to medical device and pharmaceutical companies whose success will often depend on outside auditors. The employees who will benefit include:

  • Operations managers and personnel
  • Manufacturing engineers and their managers
  • Quality managers and personnel
  • Supply chain and purchasing managers
  • Facility and Maintenance Managers

Instructor Profile:

Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 24 years he has worked in the medical device industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, Jose served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.

Jose led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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