HOFFMAN HEALTHCARE CONSULTANCY

8 bite-sized tips to help you prepare for competent authority inspections:

1 – Accurate dossiers

Make that first impression a good one. Your dossiers are the first thing the lead inspector sees, it won’t bode well if your paperwork isn’t up to date and contains inaccuracies.

2 – Mock Inspections.

Stop the guesswork and instil confidence in your team by conducting a mock inspection. This way you minimise any nasty surprises and all those involved will know what to expect. If any issues are identified a remediation action plan can be implemented and changes documented.

It’s a good idea to arrange for an external body to conduct the mock inspection so that staff receive a closer to life experience.

3 – SOPs are clear, concise, and understood by all.

Why?

1. Improved Efficiency
2. Enhanced Accountability
3. Improved Quality Control
4. Regulatory Requirements
5. Reduced Production Waste
6. Improved Workplace Safety
7. Streamlined Communication

4 – Staff training up to date.

For an ever-changing, fast paced industry it is imperative that staff receive regular, up to date training.

For you to achieve the desired results, each member of the team needs to understand the processes and their responsibilities.

Make sure there is clear documentation, accessible to all team members, communicating well-defined roles, duties, and accountabilities.

Communication is key and ensuring this is 2-way will reduce the chance of misunderstandings.

Allow your team to give summative and formative feedback on the training provided. This will help to ascertain understanding and highlight any problem areas.

5 – Correct documents in the correct places.

Don’t waste yours or the inspector’s time trying to find documents during the inspection. Ensure all documents are up to date and accessible beforehand.

If your team creates delays, it could be seen as impeding the inspection.

6 – All risks in QMS fully understood and under control.

“An ounce of prevention is worth a pound of cure” – Benjamin Franklin

A couple of hours identifying potential risks can be worth several days trying to deal with an unexpected problem, or worse still, having unidentified risks discovered by the inspectorate.

A robust risk management process will prevent the loss of time, money, inspection fails or follow-ups due to unanticipated risks.

7 – Electronic systems in place for direct and complete inspection access.

Make sure that the correct electronic systems are in place and any training for the inspector(s) is available, if required.

8 – Be prepared for any questions the inspectors may ask during interviews.

The inspector will ask many of the same questions during individual interviews, it is important to provide consistent, accurate responses.

If you don’t know an answer, don’t guess. Refer to a document, procedure or someone who will know the answer.

REMEMBER

Inspectors are human.  They are there to work with you, not against you, towards a shared goal; safe clinical trials that produce accurate and reliable results.

For more information and guidance on how to prepare for competent authority inspections, contact our team via email:

hello@hoffmanhealthcareconsultancy.com

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