TRAINING
QA
Management carries out on site training in for example Quality
System Documentation, TQM, Quality Costs, Statistical Process Control
etc.
The following are some
examples of courses provided by QA Management for groups or individuals:
-
ISO 13485:2003 Familiarisation and
the requirements for Medical Device manufacturers.
-
Technical Files and Design Dossiers compilation
to meet requirements of Medical Device Directive 93/42/EEC.
-
Electronic Records and Signatures to meet
requirements of 21 CFR part 11.
-
Clinical Trials/investigations the requirements
and legislation
-
Risk Assessments ISO 14971, Medical Devices.
Applications of FMEA, HAZOP and FTA techniques.
-
Internal Auditor training for Medical Device
manufacturers.
-
Adverse Incident control for medical devices.
The regulations and requirements for reporting.
-
FDA 510(k) preparation and submission requirements.
-
Comparison between ISO 9001:2000 and ISO
13485:2003.
-
Requirements for Cleanrooms and decontamination
and Sterilisation to meet the requirements of ISO 14644-1 etc.
-
Bringing medical devices to the market, requirements,
legislation, standards responsibilities.
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