Quality Management 101: An Enterprise Maintenance Professional's Guide

John E Lincoln Instructor:
John E Lincoln 
Friday, September 27, 2024
10:00 AM PDT | 01:00 PM EDT
90 Minutes
Webinar ID: 502217

More Trainings by this Expert

Price Details
Live Webinar
$149 One Attendee
$299 Corporate Live
Recorded Webinar
$199 One Attendee
$399 Corporate Recorded
Combo Offers
Live + Recorded
$299 $348 Live + Recorded
Corporate (Live + Recorded)
$599 $698 Corporate
(Live + Recorded)

Live: One Dial-in One Attendee

Corporate Live: Any number of participants

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)


What are the basics of an enterprise maintenance-focused Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001, the international standard for Quality Management Systems for all business or industrial systems worldwide.

This webinar will discuss basic requirements of a QMS. It will then develop those areas of QM that specifically guide CAPA (Corrective and Preventative Action), preventive / predictive (proactive rather than reactive) maintenance, routine and urgent maintenance / repairs, inspections, and continuous improvement, and some of the basic tools under SPC and 6 Sigma to achieve those goals. The emphasis of this webinar will be maintenance activities that work under the QMS "umbrella".

Why You Should Attend: "This webinar will evaluate the requirements for the foundational / basic Quality Management System (QMS), ISO 9001m and how a company's preventative and predictive maintenance programs can be enhances by the QMA requirements, as outlined in ISO 9001. Subject areas considered are:

  • Systems, Personnel
  • Buildings and Equipment, Preventive and Predictive Maintenance
  • Documentation and Records
  • Materials Management
  • Production and Laboratory
  • Validation
  • Material Rejections / Reuse
  • Post-production Issues; Analytics (descriptive, diagnostic, predictive, prescriptive)

Areas Covered in the Session:
  • A QMS ovverview
  • Systems, Personel, the Physical Plant
  • If it isn't documented, it didn’t Happen
  • Control of material, product, manufacturing
  • Preventive and Predictive Maintenance
  • Validations
  • Material /product rejection, fall-off, scrap issues
  • Complaint handling and other post-production issues

Who Will Benefit:
  • Senior management in business / industry
  • QA / RA
  • R&D
  • Engineering
  • Facilities and Maintenance
  • Production
  • Operations
  • Marketing

Speaker Profile
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.

John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

You Recently Viewed

Subscribe to our Newsletter

Subscribe for Compliance Alerts Research Reports Absolutely Free