Medical Device QSR (21 CFR Part 820), Design Control, Hazard Analysis Under ISO 14971 and ICH Q9: Pack of 3 Courses

This pack of three training courses provides 3.5 hours of training on FDA’s medical device Quality System Regulation (21 CFR Part 820), 2019 approach to compliant design control & how to develop, use and document Hazard Analysis and the Product Risk Management File and Report per ISO 14971:2007/12 and ICH Q9.

All Modules:

Module 1: Introduction to Medical Device Quality System Regulations
Module 2: Risk-based Design Control - The New Paradigm for Medical Device Design
Module 3: Hazard Analysis and Risk Management under ISO 14971:2007/2012

Part 1 : Introduction to Medical Device Quality System Regulations

Areas Covered in the Webinar:

• Regulatory basis
• Quality System
• Design Controls
• Document Controls
• Purchasing Controls
• Identification & Traceability
• Production & Process Controls
• Acceptance Activities
• Non-conforming Product
• Corrective & Preventive Action
• Labelling & Packaging Control
• Handling, Storage, Distribution, & Installation
• Records
• Servicing
• Statistical Techniques

Instructor Profile: Paul Larocque is the President of Acerna Inc., a pharmaceutical, biological, and medical device consultancy, which provides good manufacturing practice and regulatory affairs services to a global clientele. For the past years consulting, and previously in industry, Paul’s focus was FDA compliance matters.

Part 2 : Risk-based Design Control - The New Paradigm for Medical Device Design

Areas Covered in the Webinar:

• The 2019 approach to design control
• What do FDA and ISO say about it?
• How do you present it to management?
• What are the key steps in risk-based design control?
• How to implement risk-based design control in your company
• Bringing it all together – links to design and process

Instructor Profile: José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José 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. José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices.

Part 3 : Hazard Analysis and Risk Management under ISO 14971:2007/2012

Areas Covered in the Webinar:

• U.S. FDA's expectations
• The Revised ISO 14971:2007/2012 for Medical Devices
• ICH Q9 for Pharma
• The “Narrative”
• The Product Hazard Analysis
• Fault Tree Analysis (FTA)
• Design-, Process-, and Use[r]-Failure Mode, Effects and Criticality Analysis (FMECA)
• Suggested and Field-tested Risk Management File / Report, FMECA, FTA Templates
• Why and How to use the ISO 14971 "Model" in all regulated industries
• Other business reasons for use of the Risk Management File / Report.

Instructor Profile: John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years’ experience in U.S. FDA-regulated industries, and 17 years as a full-time consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. Mr. Lincoln is a graduate of UCLA.

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