QFI COLLEGE PROGRAMME OF COURSES

NEW Course - Learn all about the Principles of Ethylene Oxide Sterilisation

Providing indispensable hands-on knowledge for professionals involved in sterilisation process design, operation, control, approval and assessment, QFI launches a new 1-day training course examining the principles of ethylene oxide sterilisation.

Learning objectives:

Bio-contamination control
Principles and practice of sterilisation
Principles of ethylene oxide sterilisation
Manufacturing product release taking into account the importance of verification of process parameters
Principles of product bioburden
Biological indicator and residue tests
Determination of ethylene oxide residue

The level can be adjusted from introductory to advanced to suit the target audience.

Documentation and certification
Full course documentation is provided, consisting of a 48 page manual, Microsoft® PowerPoint presentation and (where requested), examinations and exercises. Certificates of attendance, completion or achievement, etc are offered. The course can be delivered on-site or in-house at the offices of Quality First International in London.

For bookings and registration, please contact:
e: enquiries@qualityfirstint.com
t: +44 (0) 208 221 2361

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	½ day
qfi004	Pre-Market Approval: PMA/PMA audit	Intermediate/ Advanced	½ day/ 1 day
qfi005	Pre-Market Notification: - 510(k) - Expedited, - 510(k) - Abbreviated	Advanced	½ day
qfi006	Preparation, Format and Content of 510(k) notification	Beginners	1 hour
qfi007	Determination of Substantial Equivalence	Intermediate	½ 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	½ day
qfi013	Introduction to Clinical Investigation Requirements: IDE, PMA	Beginners/ Intermediate/ Advanced	½ 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	½ day
qfi017	Types of Devices Eligible for Expedited and Special 510(k)s	Beginners	½ 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	½ day

Microbiology and Sterilisation

Code	Title	Level	Duration
qfi027	Medical Microbiology	Advanced	5 days
qfi092	The Fundamentals of Microbiology for Medical Device Manufacturers	Beginners	½ day
qfi093	Introduction to Common Industrial Sterilization Methods	Beginners	1 day
qfi094	Microbiological Control	Beginners	½ day
qfi095	Microbiological History and Folklore	Beginners	½ day
qfi096	Introduction to Bacteria	Beginners	3 days
qfi097	Identification of Bacteria	Beginners	½ day
qfi098	Classification of Bacteria	Beginners	½ day
qfi051	Industrial Microbiology and Sterilization	Intermediate	1 day
qfi052	Practical Aspects of Sterilization Validation	Intermediate	2 days
qfi053	Microbial Techniques	Intermediate	½ day
qfi054	Anaerobic Bacteriology for the Medical Device Industry	Intermediate	½ day
qfi055	Cultivation, Selection, Enumeration and Differentiation of Bacteria	Intermediate	½ 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	½ day
qfi072	Classification - Principles and Practice	Beginners	½ day
qfi077	The European Union Regulatory Domain	Beginners	½ 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	½ 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	½ 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	½ 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	½ day
qfi079	First steps in QMS compliance	-	-