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Build (or Fix) Your Quality Management System

This course is a practical crash course on 21 CFR 820 and EN ISO 13485:2012, as well as the key focal points for each element and subpart. Whether you're a startup building a Quality Management System (QMS) for the first time or a Fortune 100 medtech company looking for specific help in a QMS area, learn insider tricks from St. Cloud State University Adjunct Professor and top 40 Under 40 consultant David Amor, an expert who has led multiple QMS implementation and remediation projects for large companies and startups alike. This course focuses on the stuff you can't Google and will take a boot-camp approach to implementing and solving many common QMS obstacles, including the following:
  • Must-haves for each QMS subpart, with a focus on design controls, CAPA, production and process controls, and management review
  • Tips and tricks regarding best practices on how to achieve lean compliance by focusing on the critical elements of each subpart per FDA's Quality System Inspection Technique (QSIT)
  • Examining FDA Warning Letters/483s in the most deficient areas for companies and learning how to avoid them

Attendees will also receive proprietary templates, white papers, and additional hand-outs to help deploy and fix quality systems at their own companies.

Day 1: Quality Management System Crash Course
Date: March 15, 2016
Time: 11:00 AM PST | 2:00 PM EST
Duration: 60-minutes

Day 1 will start with a review of the QMS regulations and standards, including 21 CFR 820 and EN ISO 13485:2012. In true crash-course style, each element and subpart of the QMS will be reviewed with the information you need in a nutshell, what the QMS documentation usually looks like, and where companies get it wrong. At the end of Day 1, you will be a QMS expert capable of making compliant decisions within your organization. We’ll begin learning what the key differences between the U.S. and EU are (QSR vs. ISO 13485) and how those differences should be addressed in your QMS. We’ll continue with how the QMS is usually deployed within companies, including a brief evaluation of electronic QMS options. We’ll also review the QMS in its entirety and hear about the instructor's own experiences building systems at OEMs, CMOs, and startups. We will also cover case studies and examples—some from FDA Warning Letters and 483s—as well as different guidance documents that help companies implement various QMS subsystems.

Day 2: Spotlight on Design Controls and Production & Process Controls
Date: March 16, 2016
Time: 11:00 AM PST | 2:00 PM EST
Duration: 60-minutes

Day 2 will focus on the first two critical elements of FDA QSIT—namely design controls per 21 CFR 820.30 and production planning and control per 21 CFR 820 subpart G. If you are involved in a company that designs and develops medical devices, Day 2 will review the key emphasis points on design controls including an in-depth review of design inputs and design verification. We’ll answer questions such as the following: How many design reviews should I perform? How do I determine statistical significance for design verification? What are the differences between user needs and technical requirements? Day 2 will continue with an in-depth review of common production and process control techniques and documentation, including process mapping, process validation, and statistical process control. You will end Day 2 knowing what equipment qualification, IQ/OQ/PQ, and inspection plans are and be ready to implement them at your company.

Day 3: Spotlight on Management Review and Nonconforming Product and CAPA
Date: March 17, 2016
Time: 11:00 AM PST | 2:00 PM EST
Duration: 60-minutes

Day 3 will review one of the most overarching elements of the QMS: management reviews and involvement. Learn when, why, and how management needs to be involved within the various QMS subsystems, including CAPA. An in-depth review of nonconforming product and CAPA will give attendees a clear understanding of the sources into the CAPA process, how to escalate nonconformities into CAPAs, how to identify and investigate CAPAs, and how to build a closed-loop system that integrates with other areas of your QMS—a critical regulatory requirement.

David Amor, MSBE, CQA

Principal at Medgineering Inc.

Jamie Hartford

Managing Editor
MD+DI, UBM Canon