Corrective and Preventive Action using BS EN ISO 13485:2003
One or two day course
Software Validation Including Electronic Records & Signatures (US/FDA & EU/MDD)
Three day course
Introduction To The Medical Device Directive 93/42/EEC (MDD)
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 (US/FDA & EU/MDD)
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
Introduction To The Medical Device Directive 93/42/EEC (MDD)
Description
This three day introduction to the MDD covers the background to the Directive and its key features. The intention is to make its content and application intelligible to those in the management structure who need to understand their own roles in the organization's Quality Assurance and Regulatory Affairs activities.
