ComplianceOnline

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

$249.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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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.

Description

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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