Whitepaper: How to write to regulatory agencies when things go wrong: your essential guidance
Although good auditors base conclusions on facts, emotions will play an important part in how they perceive your company, your leadership and your quality culture.
So, what do you do?
Firstly, acknowledge receipt of the report immediately. Always be respectful and polite, never defensive or officious. Keep this immediate communication short and to the point. Commit to providing a full and comprehensive response within the permitted time frame. Emphasise your total commitment to fix the underlying causes and to address any immediate risks…
Related content from this organisation
- On-demand webinar: An update on remote and virtual auditing
- Whitepaper: Effective and fast approval of incident investigation reports
- On-demand webinar: Outsourcing selected areas of the quality system
- Whitepaper: Management of change under pressure and how to communicate with regulators in challenging times
- On-demand webinar: Managing your pharmaceutical quality system with 50 percent fewer staff