ICH Q10 / ISO 9001 Training for Pharmaceutical Professionals and ISO 13485 Training for Medical Device Professionals

The ISO 9001 / ISO 13485 training includes:

• Provide sufficient background information to clearly communicate the project’s advantages to the company and their individual areas.

• Provide a clear vision of the finished product they will develop and install as a team, using documentation examples from other registered companies.

• Clearly define the intent and specific application of the requirements of the standard to the current operation.

Review the sequence and nature of the tasks listed in the project plan including:

• develop approach for informing and updating all employees;

• establish quality system documentation structure and document control techniques after reviewing samples from templates;

• review the changes/additions recommended by the consultant for the quality manual and procedures;

• review internal documentation and practices for all requirements;

• review PharmOut’s questionnaire for gap analysis review.

Back to Practical Implementation of ISO 9001 and 13485.

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