GMP Compliance ISO 9001 / 13485 Training for Medical Device and Pharmaceutical Professionals
This training is ideal for beginning an ISO compliance project. We pride ourselves in our affordable and practical approach to implementing ISO 13485 systems. Aimed at key stakeholders in an organisation, it will:
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Provide an idea of the finished product they will create and install as a team, using documentation examples from other companies.
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Concisely identify the objective and specific application of the requirements of the standard to the current operation.
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Give a clear image of the project’s advantages to the company and their individual areas.
The training will also review the sequence and nature of the tasks listed in the project plan including:
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The communications strategy for informing and updating all employees.
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Establishing the quality system documentation structure and document control techniques after reviewing samples from templates;
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Reviewing the changes/additions recommended by the consultant for the quality manual and procedures;
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Review internal documentation and practices against the requirements of the standard.
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Undertaking PharmOut’s questionnaire for gap analysis review.
Expert Regulatory knowledge
If you are a Medical Device company, trying to comply with:
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ISO 13485 Medical Devices, or
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QSR / 21 CFR 820
Status of the standards
The ISO 13485:2003 Standard was effective July 15, 2003.
ISO 13485, supersedes EN46001/2 for Medical Devices. In essence the procedure for certification is the same as that for ISO 9001.
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Training
GMP Compliance
