A preview a Edyta's top tips to being inspection ready

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 with this we spoke to Edyta Zbirog-Lukawska, Central Europe Quality and Compliance Adviser (Affiliate Process and Training Adviser) to hear her top tips on how to fully prepare and ensure that you are inspection ready.

Watch the preview below or view the full piece here.

Mock Inspection Workshop: Put practical skills to the test

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, Roche will be guiding you through their recent inspections. With interactive break-out sessions and real life case studies, they will be putting your knowledge and practical skills to the test, to ensure you leave confident that you ARE inspection ready.

Market Report | Are you ready for your next Clinical Trial Inspection?

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 Sponsors and CROs.

We surveyed a number of clinical trial professionals about their organisation's readiness for inspections and have put them into this handy market report.

Creating a Culture of Clinical Trial Inspection Readiness

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. 

In this exclusive interview with Nancy Meyerson-Hess, Chief Compliance and Regulatory Officer, eMQT and Former Head of Clinical Operations and Compliance, Grünenthal we discuss the challenges and solutions of creating and maintaining a a culture of Clinical Trial Inspection Readiness. 

Past Presentation: Inspection Readiness during TMF Transformation - AstraZeneca

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.

Being Inspection Ready: Top Tips And Warnings

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. Pharma IQ invites the expertise of Andy Fisher Senior GCP Inspector MHRA on a list of common TMF failings.

Alongside a number of other EU member states, Andy was recently involved in drafting guidance that the EMA is due to publish shortly. This draft guidance for TMF will replace what is currently in volume 10.

Case Study: CRO Oversight from a Smaller Sponsor Organisation

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 CROs
  • Develop strategies to overcome limited resources from the perspective of smaller sponsor
  • Best ways to produce evidence of oversight

View the presentation from last year's GCP Inspection Readiness conference here to find out below

If you're interested in attending GCP Inspection Readiness 2019, you can read more here.