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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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AdvQSS Client Serv ices
ADVQSS will work with you to address all of your needs including the following:
- Quality system development and compliance
- 21 CFR Part 820 (FDA)
- EN ISO 13485:2003
- Canadian Medical Devices Regulation (CMDCAS)
- 93/42 EEC Medical Device Directive as amended by 2007/47
- 98/79/EEC, In-Vitro Diagnostic Directive
- 90/385/EEC, Active Implantable Medical Devices Directive
- Japan PAL (Pharmaceutical Affairs Law)
- Improvements to existing quality systems
- FDA Warning Letters and 483 responses
- Adverse event reporting and product recalls
- 3rd party Notified Body/quality system registrar corrective action plans
- Quality system audits and gap analyses
- 2nd party supplier audits
- Technical documentation required for CE Marking
- 510(k)s and Canadian medical device license applications
- On-site training specific to client needs (CAPA, complaints, risk management, auditing, etc.)
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