Risk Analysis & Human Factors Engineering

The Center for Professional Advancement
Amsterdam, Netherlands

Course Format: Classroom | E-learning | Virtual Class | Online | On-site | Blended | Self-paced

Course Description:

'' This course will review the current regulations and expectations for the use of risk management processes and methods in the life cycle of medical devices. We will discuss the use of the ISO 14971:2000 standard and FDA¡¯s guidance documents on Human Factors Engineering to provide a clear understanding of what techniques to use and when they should be implemented. Practical workshop activities will provide guidance on how customer use and potential misuse information can be acquired and used, as well as actual performance of various risk analysis techniques. The course will also provide guidance on what type of risk analysis should be performed at each phase of the medical device history, from early design concepts through use in the field.

This course is designed for those who work in the medical device industry and who currently are or wish to design and sell their products in US, Europe and other parts of the world. This includes, but is not limited to those in the following functions:

R&D and Quality Engineering
QA or Regulatory
Engineering and Manufacturing
All participants will gain tools to incorporate risk analysis throughout the quality system in compliance with global regulations and to ensure safe devices.
...''

Phone:+31/20/638.28.06

School Address:

Corporate Office
Box 7077, 44 West Ferris Street
East Brunswick, NJ USA 08816-7077
Phone: (732)238-1600
Fax: (732)238-9113
Email info@cfpa.com

Europe Office
Oudezijds Voorburgwal 316A, 1012 GM
Amsterdam, The Netherlands
Phone +31/20/638.28.06
Fax +31/20/620.21.36
Email amsterdam@cfpa.com



Jobs & Resumes: Amsterdam
Houses & Roommates: Amsterdam

Clean Room Technology
Powder Mixing Technology
Auditing for cGMP Compliance
Starch: Chemistry, Properties and Applications
Food Extrusion Technology
Complaint Procedures for Medical Devices
Microencapsulation and Particle Coating
Nanotechnology
ISO 13485, ISO 9001 and QSR Regulations for Medical Device Companies
Project Management
Gums and Hydrocolloids
Microencapsulation and Particle Coating
Documentation Management and Control
Analytical Methods Validation for FDA Compliance
Drug Product Stability and Shelf-Life
Microbiological Control and Validation
Process Validation for the Pharmaceutical and Medical Device Industry
Non-Clinical Drug Safety Evaluation and Drug Development
ADME: Absorption, Distribution, Metabolism and Elimination

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