NSF Health Sciences, Pharma Biotech
Consulting, Auditing, Testing, Training and Regulatory Support
How to Write To Regulatory Agencies When Things Go WrongNSF Health Sciences, Pharma Biotech
Responding to severe regulatory criticism? Need some essential guidance? This white paper by Martin Lush includes step-by-step guidance on how to write to regulatory agencies when things go wrong.
The scene: It's Friday, it's late and you are just leaving for the weekend. The inspection you hosted two weeks ago remains a painful memory. The exit meeting didn't go well.
There were five major observations all relating to your quality system. When your boss enters your office, you know it's not to wish you a good weekend. She looks stressed, anxious and keen to offload a big problem.
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