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Training Compliance Tips
- Ensure training provisions when employees move to other positions within the organization.
- Consider refresher training in instances where employees are cross-trained on multiple activities and there is the potential for a significant time lapse in performing them.
- All temporary/contract employees need a formal, documented training plan.
- Identify training requirements for executive management. No employee, regardless of position, should be exempt from training.
Management review, quality records, complaints, recalls, CAPA, internal audits are areas to consider for executive management training.
- Recognize that authoring a procedure does not necessarily mean that employee is qualified to train other employees, especially a large group.
- Training effectiveness verification (as required by ISO 13485) can take many forms. Consider options other than formal quizzes/exams.
- Self-study is the least effective method of training. It should be used sparingly.
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Industry Sites
FDA Center for Devices and Radiological Health:
www.fda.gov/cdrh/
ISO:
http://www.iso.org
SCC ( Standards Council of Canada):
http://www.scc.ca
TPD (Therapeutic Products Directorate):
http://www.hc-sc.gc.ca/dhp-mps/index_e.html
Listing of Competent authorities:
http://europa.eu.int/comm/enterprise/medical_devices/ca/list_ca.htm
EU Guidance Documents:
http://ec.europa.eu/enterprise/medical_devices/meddev/
AAMI (Association for the Advancement of Medical Instrumentation)
www.aami.org
CEN (European Commission for Standardization):
http://www.cen.eu
GHTF (Global Harmonization Task Force):
http://ghtf.org
SDRAN (San Diego Regulatory Affairs Network):
http://sdran.org
ASQ Biomedical Division:
http://asq.org/biomed/
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