3-Hour Virtual Seminar on Bootcamp on Quality Management System (QMS)?

John E Lincoln Instructor:
John E Lincoln 
Monday, September 23, 2024
10:00 AM PDT | 01:00 PM EDT
3 Hours
Webinar ID: 502216

More Trainings by this Expert

Price Details
Live Webinar
$299 One Attendee
$349 Corporate Live
Recorded Webinar
$549 One Attendee
$499 Corporate Recorded
Combo Offers
Live + Recorded
$559 $848 Live + Recorded
Corporate (Live + Recorded)
$799 $848 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 a Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001.

ISO 9001 is an international standard for Quality Management Systems for all business or industrial systems, and is used as such by companies worldwide. It emphasizes the key principles that should be emphasized and those areas to be avoided, based on regulatory inspection / audit findings. It will discuss the key parts of ISO 9001, especially how it applies to manufacturing, but with application suitable for many different business activitie. ISO 9001's principles are incorporated in the US CGMPs (Good Manufacturing Practices) for pharma, 21 CFR 210 and -211 (actually the other way around), and in ICH Q7, GMPs for APIs (Active Pharmaceutical Ingredients). Further emphasis on QMS principles will be discussed by evaluating the conduct of a regulatory audit, and the major areas to address.

Why You Should Attend: "This seminar will evaluate the requirements for the foundational / basic Quality Management System (QMS), ISO 9001m and how most QMS' requirements build upon that foundation. Then it will go into a detailed analysis of the basic requirements of ISO 9001 and what that means for the typical manufacturing company (and others). Subject areas considered are:

  • Systems, Personnel
  • Buildings and Equipment
  • Documentation and Records
  • Materials Management
  • Production and Laboratory
  • Validation
  • Material Rejections / Reuse
  • Post-production Issues and Auditing

Areas Covered in the Session:
  • A QMS ovverview
  • Systems, Personell, the Physical Plant
  • If it isn't documented, it didn’t Happen
  • Control of material, product, manufacturing
  • Laboratory Controls
  • Validations
  • Material /product rejection, release
  • Complaint handling and other post-production issues
  • A typical regulatory Audit of the QMS

Who Will Benefit:
  • Senior management in business / industry
  • QA / RA
  • R&D
  • Engineering
  • 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.

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