How this simple checklist can prepare you for your next inspection
Whether your clinical trial inspection is
looming or seems further away, it is critical that you remain prepared.
However, often the preparation process for an inspection can be stressful, with
each stage presenting different challenges to ensure a culture of readiness is
upheld.
Recent changes to regulations, e.g. the amendment of ICH E6, mean that it is now more vital than ever for clinical professionals to understand the latest regulations and align trials to these. The nuances of this must be understood and implemented effectively, so it is essential that those overseeing clinical trais have the knowledge to do so, this is where we come in.
As I'm sure you're aware the difficulties that come with clinical trials. These take on average 12 years to complete and millions of pounds of investment so failing an inspection, or the fear of critical findings as setbacks, cannot be an option. Delays to your clinical trials result in an increased time to market, resulting in considerable business implications - so what must you do in order to prepare?
Key elements when preparing for an inspection include:
- Sponsor oversight
- CAPAs
- Electronic
system access
- Carrying out mock inspections and more
Ahead of GCP inspection Readiness Forum 2019, we have created a handy checklist to help you on your journey to quality compliance and a consistent culture of readiness aligning to these guidelines. View the piece below:
What are your key pain points? Explore each of these points in greater detail in this checklist to help you and your team pave a clear path to ensuring a culture of readiness. These challenges cannot wait until your next inspection, by tackling these now it will allow for the removal of any potential delays and also drive a consistent culture of readiness.
Often organisations will seek the need for extra training shortly prior to their next inspection, although this may seem effective it often poses the risk of rushing stages and lacking thorough preparation necessary. By developing a culture within your clinical trials that's continuously prepared, aligned and aware of regulations and best practice it removes the worry of inspection and critical findings.
Ensure that this journey to readiness is clear every step of the way at this year's forum in September, here we will be following an agenda that taps into each stage of preparation. Through interactive sessions, concluding with a mock inspection workshop, we will be ensuring that you and your team leave fully inspection ready with a toolkit to follow through this checklist thoroughly.
Find out more about this year's GCP Inspection Readiness forum will guide you on your journey to becoming inspection ready. Join like minded peers as you engage in high levels of interactivity and overcome your challenges in: creating a culture of quality, sponsor oversight, CAPAs, QMS and understanding the regulatory landscape. Complete your journey with our onsite mock-inspection where you will give your new skills a trial run and leave with the confidence, you are inspection ready.As the only European forum where Clinical Quality and Operations Professionals join together in collaboration to benchmark with their peers in Big Pharma, SMEs and CROs, the GCP Inspection Readiness forum will give you the practical solutions you have been looking for.