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Who should attend ISO 13485, ISO 14971, Quality Document Management, and Risk Management for Medical Devices
Senior quality managers, Quality professionals, Regulatory professionals, Compliance professionals, Production supervisors, Manufacturing engineers, Production engineers, Design engineers, Process owners
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Seminar Summary:

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. (see full course description)

 
 
 

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print the agenda print agenda for the ISO 13485, ISO 14971, Quality Document Management, and Risk Management for Medical Devices seminar

 

Training Course Syllabus:


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 organization.

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

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

Seminar Summary:

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. (see full course description)

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