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.
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.
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.
