GCP | Resource Centre: Infographics, reports and more

Inspection readiness is an ongoing task, as it involves not only mock inspection preparation but also efforts to ensure a consistent culture of readiness. Whether your inspection is around the corner or further in the future, attend this mock inspection workshop day for confidence in:How to effectively prepare for a...

Inspections can occur at any time; therefore the preparation can be daunting. With acute consequences, it is crucial that best practices are in place to ensure that your recorded data and documentation is compliant when the inevitable inspection comes around. This interactive, expert-led training course will give you the opportunity...

In order to prepare, pharmaceutical companies must understand the requirements and expectations of inspectors and how these can be satisfied. Pharma IQ asked Edyta Zbirog-Lukawska, Central Europe Quality and Compliance Adviser (Affiliate Process and Training Adviser), Roche, her top 5 tips to becoming GCP inspection ready.We need to embrace the...

Choosing the right Quality Management System plays an integral role in the inspection readiness journey and making sure that your company is following Good Clinical Practice. As one of the respondents mentioned:"it minimises human error and improves transparency"This infographic explores what companies want when it comes to choosing a QMS....

With recent changes amongst GCP Guidelines, including the amendment of ICH E6 it is now more critical than ever to keep up to date and ensure a consistent culture of inspection readiness. Ahead of GCP inspection Readiness Summit 2019, we have created a checklist to help you on your journey...

In the constantly evolving pharmaceutical regulatory environment, ongoing GCP inspection readiness is vital to ensure the successful launch of products. We wanted to understand where the industry is positioned in regard to inspection preparedness and the key pain points which are preventing the maintenance of a readiness culture within both...

When a culture of readiness is embedded within an organisation, the greatest level of inspection readiness can be maintained.We wanted to gain a greater understanding of the most important elements to consider when creating a culture of readiness including the training, documentation maintenance and vendor management during the clinical trial. ...

Ahead of GCP Inspection Readiness 2018 we have compiled a sample of this year's attendees. Take a look at who you can expect to meet, hear insights from and network with across the three-day event on the 20-22 November in Brussels, Belgium.If you would like more information about the event...

If you were handed with a notice for a clinical trial inspection plan right now, how would you react? - With a feeling of asserted confidence or a rush of slight concern? Wherever you think you would stand on this spectrum, use this infographic to learn from your peers’ mistakes....

GCP Inspection Readiness is a unique forum providing insight into best practice through interactive and hands on sessions to ensure a consistent culture of readiness. Follow a clear journey to inspection readiness across the two-conference days as well as a data integrity pre-conference training day and post-conference on-site mock inspection...

Explore the range of opportunities available to you at the 2nd Annual GCP Inspection Readiness Forum in this comprehensive business development pack.Take this unique chance to showcase your solutions and network with leading organisations within the clinical trial and quality compliance community. This conference offers a wide range of opportunities...

At the TMF and Inspection Readiness Forum, AstraZeneca presented a session on 'Inspection Readiness during TMF Transformation'.Fill out the form here to download the presentation slides >>If you are interested in finding out more about GCP Inspection Readiness 2019 then you can view the full event guide here.

Read insights from Mallorie Mitchell-Dellac, Senior Manager, Clinical Quality Assurance, BTG on her perspectives from a smaller sponsor organisation on CRO Oversight. Including discussions on:Requirements for effective sponsorship oversight of CROsDevelop strategies to overcome limited resources from the perspective of smaller sponsorBest ways to produce evidence of oversightView the presentation...

GCP Inspection Readiness returns for it's second year as we ask you: Are you inspection ready?Whilst it is well known that building and maintaining a culture of quality is crucial to the success of a clinical trial, how can you be sure that your methods are best practice? Follow the...

Preparation for an inspection can be a long process, and with many confusing and difficult steps to cover it can be extremely stressful. The weight of repercussions that critical findings or missed steps include are both timely and costly in a very time and financially sensitive environment.In order to help...

Wherever your pain-points might lie, our full-day mock inspection workshop, on the 19th September, will give you the tools you need to overcome your challenges in readiness activities, preparing for interviews, evolving your processes during the inspection and even follow up activities.  Industry experts Elke Ufer, Grünenthal and Edyta Zbirog-Lukawska,...