How to Establish and Maintain Device Design and Development (Design Control)

Description

Facilitating the device design and development process with proper use of design control.

Follow the 10 required steps (bothUS FDA and EU MDR) to design contol compliance in R&D. How are the requirements of product risk management and human factors / use engineering incorporated and when. Use these requirement to reduce scheduling uncertainty, incomplete projects when time is running out, increased product liability, while assisting in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line.

Why Should You Attend:

The medical device design and development process is the start of new and major changed product development, but also the source of serious "unintended consequences" having negative outcomes for users in the field. Design control is one key way in which the US FDA (and the EU) expects companies to manage the regulatory requirements of design and/or change control. How can the FDA's Design Control requirements, 21 CFR 820.30, actually facilitate this? How can this be done from a project's inception? How can a Project Leader ensure critical elements are not ommitted until late in the project when disaster looms? Where is ISO 14971 Risk Management and IEC 62366-1 Use Engineering mandated - and how? Design control requires the implementation of 10 formal methods with documented, and defensible rationale. Use these tools to bring predictability to your company's product development process. Further use them to improve your company's capture of IP (intellectual property).

Areas Covered in the Webinar:

• Meet key design control requirements of the CGMPs/ISO

• The 10 Key Elements of Design Control

• 21 CFR 820.30, EU MDR, and ISO 13485 7.3

• Risk Management (ISO 14971)

• Use Engineering (IEC 62366-1 +)

• SOP Basics

• A Suggested Design Control Project Management Template

• US FDA and EU MDR documentation requirements

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies to ensure compliance to the design control requirements of 21 CFR 820.30 and ISO 13485 7.3 - under cGMP and EU MDR/CE-marking compliance. It will discuss and provide examples of the 10 key design control milestones and associated tasks and provide a major example for immediate use. This applies to companies in the Medical Device, and combination products fields. The employees who will benefit include:

• Senior management
• Regulatory Affairs
• Quality Assurance / QAE
• Production
• R&D and Engineering
• All personnel tasked with any new or changed device development responsibilities, and those who soon hope to be

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. John 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, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.

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