ACDM Webinar - Preparing for a Regulatory Inspection - 13th December 2016
This webinar provides an overview of the preparation and tasks required in “Preparing for a Regulatory Inspection”. The session will focus on the basics for ensuring your inspection achieves the best possible outcome from an inspection for your organisation.
Who should attend?
Is your organization due for a scheduled regulatory inspection? Has your project been selected to be reviewed? This webinar provides an overview of the critical preparation tasks required to ensure your inspection achieves the best possible outcome for your organization.
You will understand what regulatory authorities are and what they do, and then learn how they conduct inspections and the key information they are looking for.
This webinar is for anyone working in data management or statistics who deals with clinical data intended for regulatory submission. Inspectors can ask to interview any member of staff during an inspection so be prepared!
• What are Regulatory Authorities and what do they do?
• What is the EU Directive and the UK Statutory Instrument?
• How do they conduct inspections and what do they inspect against ?
• What do inspectors look for? What do you need to prepare?
• Basic Audit Conduct
Date: 13 December 2016
Time: 12:00 - 13:30 GMT
Duration: 90 Minutes
Instructor: Jon Wood
Jon Wood has a degree in physiology and brings nearly 25 years of industry experience across project management, biometrics and strategic sourcing roles within blue chip pharma and Contract Research Organisations.
Click here for online booking
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