Quality First International

QFI COLLEGE PROGRAMME OF COURSES

NEW one-day seminars

Principles and practice of remedial action: non-conformity, corrective and preventive actions

Learn all about the Principles of Ethylene Oxide Sterilisation

US Regulations

Code

Title

Level

Duration

qfi001

Introduction to the Code of Federal Regulations

Beginners

1 hour

qfi002

Good Manufacturing Practice

Beginners

1 hour

qfi003

Pre-Market Controls

Beginners

day

qfi004

Pre-Market Approval: PMA/PMA audit

Intermediate/
Advanced

day/
1 day

qfi005

Pre-Market Notification: - 510(k) - Expedited, - 510(k) - Abbreviated

Advanced

day

qfi006

Preparation, Format and Content of 510(k) notification

Beginners

1 hour

qfi007

Determination of Substantial Equivalence

Intermediate

day

qfi008

The Role of Guidance in US Medical Device Regulation

Beginners

1 hour

qfi009

Dealing with US Regulatory Filings

Beginners

1 hour

qfi010

QSR

Advanced

2 days

qfi011

Design Control for US Marketed Medical Devices

Advanced

1 day

qfi012

Introduction to Medical Device Reporting

Intermediate

day

qfi013

Introduction to Clinical Investigation Requirements: IDE, PMA

Beginners/
Intermediate/
Advanced

day/
1 day/
10 days

qfi014

Registration and placement of medical devices on the US market

-

-

qfi015

Application of US QSR

-

-

qfi016

Establishment Inspections - 483, etc.

Beginners

day

qfi017

Types of Devices Eligible for Expedited and Special 510(k)s

Beginners

day

qfi018

How to Obtain Class II 510(k) Exemptions

Intermediate

2 hours

qfi019

Determination of Automatic Class IV Designation for Devices

Beginners

1 hour

qfi032

A Practical Guide to USA Regulatory Compliance

Intermediate

5 days

qfi033

Preparation of US Pre - Market Notification  [510(k)]

Advanced

1 day

qfi043

US Medical Device Regulations

Beginners

1 day

qfi044

Beginners Guide to FDA Regulations

Beginners

1 day

qfi062

Compliance with FDA Regulations

Advanced

1 day

qfi100

A Practical Guide to USA Regulatory Compliance

Intermediate

day

Microbiology and Sterilisation

Code

Title

Level

Duration

qfi027

Medical Microbiology

Advanced

5 days

qfi092

The Fundamentals of Microbiology for Medical Device Manufacturers

Beginners

day

qfi093

Introduction to Common Industrial Sterilization Methods

Beginners

1 day

qfi094

Microbiological Control

Beginners

day

qfi095

Microbiological History and Folklore

Beginners

day

qfi096

Introduction to Bacteria

Beginners

3 days

qfi097

Identification of Bacteria

Beginners

day

qfi098

Classification of Bacteria

Beginners

day

qfi051

Industrial Microbiology and Sterilization

Intermediate

1 day

qfi052

Practical Aspects of Sterilization Validation

Intermediate

2 days

qfi053

Microbial Techniques

Intermediate

day

qfi054

Anaerobic Bacteriology for the Medical Device Industry

Intermediate

day

qfi055

Cultivation, Selection, Enumeration and Differentiation of Bacteria

Intermediate

day

qfi103

Cleaning and disinfection of equipment returned for service or repair

Beginners

1 hour

qfi104

Cleanrooms and cleanroom procedures - Why are they so important?

Beginners

1 hour

qfi040

European and Global Biological Safety

Beginners

1 hour

qfi048

Designing Re-useable Sterile Medical Devices

Intermediate

1 day

European Regulations

Code

Title

Level

Duration

qfi070

Beginner's Guide to the Medical Devices Directive

Beginners

1 day

qfi071

The Medical Devices Directive and You

Beginners

day

qfi072

Classification - Principles and Practice

Beginners

day

qfi077

The European Union Regulatory Domain

Beginners

day

qfi078

Complying with Design Control Requirements of the Medical Devices Directive

Beginners

1 day

qfi081

A Practical Guide to European Regulatory Compliance

Beginners

1 day

qfi042

EC Product Classification

Beginners

day

qfi045

Complying with the New European Medical Device Regulations

Intermediate

1 day

qfi046

The Role of European Medical Device Regulation in European Healthcare

Intermediate

1 day

qfi059

EU Post-Production Notification :The Medical Device Vigilance System

Intermediate

day

qfi060

EC Product Classification

Advanced

1 day

qfi020

Auditing Compliance with the Medical Devices Directive

Advanced

2 days

qfi021

Implementing the Medical Devices Directive

Advanced

3 days

qfi025

Preparation of Technical Documentation and EC Product Design Dossiers

Advanced

3 days

qfi031

Annex II at a Glance

Advanced

day

qfi034

Compliance with Annex II of the Medical Devices Directive

Advanced

1 day

qfi035

EC Design - Examination according to Annex II of the MDD

Advanced

3 days

qfi037

Medical Devices Directive Technical Specialist Professional Training

Advanced

3 days

qfi038

Lead Assessor Training - EN 46001

Advanced

2 days

qfi039

Lead Assessor Training - MDD

Advanced

1 day

Quality Management

Code

Title

Level

Duration

qfi075

Introduction to GMP

Beginners

1 day

qfi076

Principles and Practice of Quality Auditing

Beginners

day

qfi079

First steps in QMS compliance

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-