This course provides comprehensive training on the US FDA Quality System Regulation (QSR) for medical devices, focusing on critical aspects such as design controls, verification & validation (V&V), document management, and risk-based decision making.
Proper adherence and documentation of teh FDA's Design Control and Validation requirements are key to any medical product project's success.
This seminar will provide valuable guidance to regulated companies in development and implementation of Design Control Planning and Techniques for new product development under 21 CFR 820.30, "Design Control", and ISO 13485 7.3. Design Verification and Validation, Mandatory Device Safety/Risk and "as needed" Human Factors are also discussed. Also regulatory compliance proof of "progress against plan", and other activities requiring a planned documented rationale. It should be an important part of a company's IP (Intellectual Property). Follow the 10 required steps (both US FDA and EU MDR) to design control compliance in R&D. Regular use of a few simple but powerful tools will virtually eliminate "fire fighting" in a new project. Regular use can contribute greatly to reduction of scheduling uncertainty, incomplete projects when time is running out, increased product liability, assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line.
Why Should You Attend
The FDA expects companies to manage the regulatory requirements of design control, and verification/validation with consideration of all applicable standards. How can the FDA's Design Control requirements, 21 CFR 820.30, which include a V&V component, actually facilitate this? The EU MDR and their notified bodies are no different. How can this be done from a project's inception? How can a Project Leader ensure critical elements are not omitted until late in the project when disaster looms? How does this translate into better, safer product in the field. Growing high-profile field problems indicate that much design control is perfunctory, poor or non-existent. Service Risk Management ad Files are an FDA requirement in this process. Human Factors / Use[ability] Engineering is also required in design if the device "interface" applies.
Course Content
Day 01
Session 1: Medical Device Development - Design Control and US FDA CGMPs and EU MDR / ISO 13485
- Introduction
- Design Control Under 21 CFR 820.30
- Design and Development Planning under ISO 13485:2016 7.3
- The U.S. FDA's DHF
- The EU MDR's D&DPF
- MDR's "General Safety and Performance Requirements"
- Device Classification -- U.S. FDA vs. EU MDR
- Design Files' "Typical" Contents
- The US DMR and DHR / Lot / Batch Record; the EU Versions
- TD Expected Contents
- The Future / Trends
Session 2: Medical Device Development - Risk Management
- Risk Management / File Under ISO 14971 - Device and QMS
- Narrative
- Hazzard Analysis
- FTA
- D-, P-, and U-FMECA's; Review - Residual Risk, Benefit / Risk Analysis
Session 3: Medical Device Development - Human Factors / Use Engineering
- Human Factors / Use Engineering Under IEC 62366-1:2015, -2:2016
- The User Interface
- The 9 Stages
- The HF / UE File
Summary
Review; Q & A
Day 02
Review of Day One
Session 4: Master V& V Planning
- V&V; “Working” Definitions
- Key Areas in Product Validation
- Key Equipment, Process, Software and QMS V&V Activities
- The Master Validation Plan
- Requirements
- Protocols / Test Cases; Proving (V&V) the Requirements
- DQ, IQ, OQ, PQs, and PPQs
- The Test Report
- Life Cycles; Regulatory “Hot Buttons”
Session 5: Software Verification and Validation
- Documentation - The 10 Elements “Model” “Rule”
- V&V “Models” - For the 4 Types of SW Validations, including 21 CFR Part 11, “Electronic Records / Signatures”
- Legacy, Hybrid, New and ER / ES Systems
- Life Cycle and “Cloud” Considerations
- Types of Testing; “Typical” Test Report and Test Case Samples
- GAMP® 4 & 5
- IEC 62304
Session 6 - Data Integrity and Cybersecurity
- Data Integrity and Cybersecurity - US FDA Requirements
- FDA Guidance Documents
- US NIST Recommendations
- Software Updates
- Software Patches
- The System Administrator
- Further Validation Considerations
Summary / Review Day 1 & 2 and Q&A
END Day Two
Course Provider
John E Lincoln,
Principal ,
J. E. Lincoln and Associates LLCJohn E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry 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 / CGMP audits and 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, he 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. He is a graduate of UCLA.
Who Should Attend
This seminar is designed to provide valuable guidance for regulated companies seeking to ensure full compliance with the design control requirements of:
- US FDA 21 CFR 820.30
- ISO 13485 - Section 7.3
- cGMP
- EU MDR / CE-Marking Compliance
Participants will learn about the 10 key design control milestones and practical examples that can be immediately applied to improve compliance and product development processes.
Applicable Industries:
- Medical Device Manufacturers
- Combination Products Companies
Ideal for Employees Involved In:
- Senior Management
- Regulatory Affairs
- Quality Assurance / Quality Assurance Engineering (QAE)
- Production
- Research & Development (R&D)
- Engineering
- Any personnel tasked with new or changed device development
This course empowers professionals to successfully implement design controls, verification, and validation strategies in line with regulatory expectations, reducing compliance risks and improving product safety and effectiveness.
