Audits and inspections are a fact of life when running clinical trials. This course is designed to provide a basic understanding of the inspection preparation in clinical drug development (except medical devices) and will demonstrate the importance to ensuring good data quality, as a basis of successful inspection outcome.This Inspection Readiness for CRAs and PMs webinar will fulfill your expectations in a very practical way. It is an interactive approach to comprehend and prepare inspections, and you can learn at your own pace.
Documents and materials related to this course are included
Globally recognised certificates awarded after test completion
This course has been granted PharmaTrain Recognition
Live online training: 2h (14h00 – 16h00)
Does your institution and teamwant to be prepared for an (upcoming) inspection? If so, then this course is ideal for you. We will show you what to do before, during and after the actual inspection and how to respond to the inspection report. It is designed to provide a basic understanding of the inspection preparation in clinical drug development (except medical devices) and will demonstrate the importance to ensuring good data quality, as a basis of successful inspection outcome. This Inspection Readiness for CRAs and PMs webinar will provide delegates with advice on the differences between audits and inspections, preparing and providing information to inspections, tips how to improve communication and advice on how sites respond to inspection findings. This course will fulfill your expectations in a very practical way. It is an interactive approach to comprehend and prepare inspections, and you can learn at your own pace.Read this article for more information.
Inspection concepts (FDA, EMA, regulatory authority)
Current inspection standards
Different approaches to preparing and participating investigator site inspection
Responding inspection findings
Be able to differentiatebetween audits and inspections
Learn how to prepare and provide information to inspectors
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.