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Software Validation / Introdution to EN 62304
28 February to 29 February 2012
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Medical Device Sterilization for Manufacturers
23 April to 27 April 2012
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Classroom Training Courses

Date

Course

Venue

23th April to 27th April 2012

Medical Device Sterilization for Manufacturers

Hotel Mäster Johan, Malmö, Sweden

Spring 2012

Software Validation / Introduction to EN 62304 

Örestads Golfklubb, Lomma, Sweden
Spring 2012
 
Nondevice Software Validation / FDA 21 CFR Part 11 / eSignature and eRecord compliance
 
On demand

Corrective and Preventive Action using BS EN ISO 13485:2003

 
 
Medical Device Sterilization for Manufacturers
Description
 
The course covers microbiological quality and inactivation kinetics sterilization validation for irradiation, moist heat and ethylene oxide procedures liquid sterilants aseptic processing use of biological indicators and ISO13485: 2009 requirements.

The new sterilization standards will be used as reference for the course.

Optional exam with certificate from University of Manchester.
 
Price
 
€ 3.200  incl.  training course, 4 x lunch, full documentation and exam.
 
Who should attend? Tutors Benefit of attending Programme (5 days)
 
 
Corrective and Preventive Action using BS EN ISO 13485:2003
Description
 
BS EN ISO 13485:2003 (harmonized with the MDD) requires a manufacturer to establish procedures for the implementation of corrective and preventive action, a CAPA system. This has been recognized as a requirement by most regulatory authorities including USA, Canada, China and Japan.
Compliance involves the ability to analyze and deal with process problems, for example in development, production, distribution and servicing, as well as customer communication including complaints.
 
Who should attend? Tutors Benefit of attending Programme (1 day)
 
 
Software Validation Including Electronic Records & Signatures
Description
 
The FDA Quality System Regulation requires compliance with the validation requirements for software as expressed in 21 CFR 820.30(g), 70(i), 75 and 21 CFR relating to electronic records and signatures.

EU Medical Devices Directives (MDD) requires that software must be designed to ensure the repeatability, reliability and performance of these systems according to the intended.

This course describes the requirements and how compliance can be achieved.
 
Who should attend? Tutors Benefit of attending Programme (2 days)