Syllabus of practical QA & RA training at CardioComm Solutions Inc.

 

MODULE 1

Description

Workshop 1

Description

Introduction to Quality Assurance (QA) and Regulatory Affairs (RA) in the Medical Devices Industry

Introduction, Program overview, Workshops and hands on training, assessment criteria, practical training in a company environment

Description of the Medical Device Industry

What is Quality Assurance

What is Regulatory affairs

Who is the QA and RA professional, the job description, position available

Medical Devices regulation in Canada, US and EU

What are medical devices and their classification

Software as a medical device, regulatory clearance

Introduction to quality in medical devices

Exam 1

 

Intro to workshops

The purpose of the workshops and expectations

Standard Operational Procedures, layouts and readability

Identifying medical devices and their classification

Each participant will be working on one section of the Quality Manual and will provide for an analysis and review

Module 2                              

 

Workshop 2

 

The QMS

The Quality Management System (QMS) and the Quality Manual

Content of a QMS and Standard Operational Procedures

The Quality assurance function

The ISO 13485 standard

Quality by design

Exam 2

ISO13485

Standard Operational Procedures, layouts and readability

Review of applicability of ISO 13485 2003/2016 CMCAS

FDA requirements for medical devices, actual compliance of products

EU requirements for medical devices, actual compliance of products

 

Module 3

 

Workshop 3

 

Design controls

The QMS – Design Controls throughout the Product Development Lifecycle

Design Control, Elements and Regulatory Requirements 

The Device History Records (DHR), Device Master Records (DMR) and Device History Files (DHF)

Design Review

Design Transfer Requirements and  Traceability Matrix

Verification and Validation

Usability Engineering as a Core Design Control Tool

Exam 3

The qualified supplier

Selecting and Managing Qualified Suppliers, How To Select, Evaluate, Monitor and Control ISO 19011:2011 Guidance Documents, criticality and documentation

Associated SOPs (Standard Operational Procedures, layouts and readability)

Module 4

 

Workshop 4

 

Risk management

Risk Management and  EN ISO/ISO 14971

The risk management process, Identifying, Evaluating and Controlling Risks

Complaint Management and the CAPA

Complaint Handling and QA

Complaint vs. Inquiry vs. Service and   Feedback

Corrective Action and Preventive Action (CAPA) Process

The  Medical Device Reporting Event

Complaint Trending Methods

Exam 4

RISK MANAGEMENT /CAPA

Review SOP dealing with risk management and assessment of completeness

Review SOP Complaint management

Review SOP CAPA, analyze CAPA process

Module 5

 

Workshop 5

 

REGULATORY SUBMISSIONS

Submission for a Medical Device clearance (FDA, Health Canada)

Medical device Establishment Licensing (MDEL)

Medical Device License (MDL)

European Medical Devices Directive (MDD 93/42/EEC)

European Union (EU) Competent Authorities, Authorized   Representatives and Notified Bodies

Requirements for CE Marking under the European Regulatory Requirements

Exam 5

Practical Regulatory Submissions

Completing Health Canada applications

FDA 510K

Conformance assessments

Module 6

 

Workshop 6

 

The Notifying Bodies

NB audits, MDSap program

Regulatory audits, preparation

Dealing with non-conformances (major and minor)

Exam 6

PMS

Review of the Post marketing surveillance process

SOP post marketing surveillance

Research of efficiency and safety data for medical device, and report