ISO 13485, ISO 14971, Quality Document Management, and Risk Management for Medical Devices

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Medical device manufacturing companies generate a copious number of documents when implementing a Quality and a Regulatory Management System.

Various applications are available for purchase but at a high cost and unfortunately with ongoing maintenance license fees and the use of the service provider’s cloud systems which at times becomes questionable with current cybersecurity issues we all face.

This session will take through a new paradigm in work practices for managing documentation without the need to continuously search and question obsolescence and relevancy. It will introduce the use of Microsoft Excel and hyperlinks to manage particular areas of document and project management.

You will learn how to best manage your documents, remain compliant to ISO 13485 but most importantly eliminate one of the biggest time wasters when documents are saved by one person and retrieved by a different person in your organisation.

ISO 13485:2016 will be the reference document for all matters in this course.

Learning Objectives:

Upon completing this course participants will:

  • Understand and implement a document naming convention for their department, pursuant to sections in ISO 13485
  • Understand inputs into a Quality and Regulatory Management System
  • Adopt a procedural approach when documents are saved and are continuously traceable from the time they are first created
  • Incorporate the approach as a new discipline for all current and new staff joining the organisation
  • Ensure continuous use of the new procedure through ongoing audits of the practice throughout the organisation
  • See immediate time savings when the approach is continuously used
  • Have in place a clearly defined document indexed maintainable folder structure
  • Remain compliant to ISO 13485

Who will Benefit:

This course is designed for all personnel tasked with, creating, maintaining ongoing updates of documentation associated with a Quality Management System and Regulatory Affairs. This includes individuals working in department with Quality Management Systems, Engineering and Regulatory Affairs accountabilities. The following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
  • Administrative staff
  • IT Managers and associated staff
Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 08.45 AM: Registration
  • 09.00 AM: Session Start
  • Module 1 – Document Management 101
    • The impact of technology in our daily routine – The frustrated employee and the time keeper - What does the data tells us
    • Let’s save some documents -Group exercise – current practices- Our own methodologies- Lets share our practices
    • Excel 101, power of use, the beauty of hyperlinks. Directories/Folders/Subfolders-Do we need them. Search options do we need it.
  • Morning Break
  • Module 2 – The heartbeat of a Medical Device Manufacturing organisation - ISO 13485
    • The auditor approach in assessing a Quality Management System – How to make the auditor happy and at the same time reduce time wasters
    • ISO 13485:2016 – Sectional breakdown and discussion on imperatives
    • The first document that is written in a Quality Management Document System
    • Typical templates for Policies, Standards Operating Procedures, Working Progress Instructions, Forms, Labels, Instructions for Use, Brochures, websites The FONZ or FONT
    • The last document that is written in a Quality Management System – Can it be called the Executive Summary
    • The Quality Management Dictionary – The important inclusions of terms and definitions and anomalies with the Australian Regulatory Framework (e.g. definition 3.12 against UPI and GMDN code)
  • Module 3 – The marriage of Risk assessment -ISO 14971 and ISO 13485
    • ISO 14971-Course 101
    • Risk Analysis – Criticality and its incorporation in a Quality and Regulatory Management documentation system
    • Group project - Building a risk assessment report
    • Continual data feeds into a revolving Risk report – source of information
    • Complaint handling (8.2.2), Risk Assessment and test reports
  • Afternoon Break
  • Module 4 - The Essential Requirements and Principles Checklist
    • Differences in Checklists
    • Document control of Checklist and Incorporation in Quality Management document control system
    • Data inputs in The Essential Requirements and Principles Checklist
    • Numbering system and Control of Documents (4.2.4)
    • Traceability (7.5.9) and Numbering Nomenclature
    • Let’s start building Quality Map using MS Excel
Day 02(8:30 AM - 4:30 PM)
  • Module 5 – Training and Control in a Quality Document Management System
    • Resource Management (6) and Organisation
    • Organisation Chart, Personnel Accountability, Training schedule and Control and input in a Quality Map
    • Imperatives in an employee induction program and feeds into in a Quality Document Management System
    • Control of Records (4.2.5) , numbering system and links to related Standard Operating Procedures
    • Audits (internal 8.2.4) and document inspection trail
    • Component specifications, contractual agreements and control (7.4.2)
    • Communications and Emails capture – Your Outlook files and significance within a Quality Document Management System
  • Morning Break
  • Module 6 - Requirements for Regulatory Purposes
    • Document Management System and Regulatory Affairs input -Why not adopt a Document Control approach into a submission file
    • Global requirements for a Medical Device submission application
    • NB-MED/2.5.1/Rec5 to GHTF/SG1/N063:2011, IMDRF’s IMDRF/RPS WG/N9Final: 2014 and elements for inclusion into a Document Management System
    • The criticality of the GMDN code within your Regulatory Management Documentation System and section 4.2.3 ( Medical Device File)
  • Module 7 – The Regulatory Documentation Management System
    • Design and Development (7.3) and Documentation Management – An introduction
    • Product Life cycle to Product approval
    • The technical file , Inputs and links to the Quality Management Document System
    • Document Management hierarchy for TGA submissions of various Risk classifications – Regulatory affairs 101
  • Afternoon Break
  • Module 8 - A review
    • Review of all inputs into let’s call it “ Quality Master and Regulatory Master”
    • Workshop-Mission Clean up
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Speaker: George Azoury, Chief Executive Officer,RQSolutions Pty Ltd

George Azoury is principal and founder of RQSolutions. A leading consulting company located in Sydney, Australia, servicing the Medical Device Industry since 2002. Previous to this, George has held various local and regional positions in Regulatory, Compliance and Health Economics in a number of national and multinational companies. George is well known at both a local and global level with involvements with a number of companies ranging from the start-ups to the well-established manufacturing facilities in Europe, US and the Asia Pacific region.

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