Training Course & Event Calendar
Preparing For A Regulatory Inspection – Focus on Data Management
Course Date: June 6, 2018
Type of Course: Webinar
Course Trainer: Jon Wood – Jon has spent nearly 30 years in the drug development industry, working for large pharma/biotech and CROs and has extensive experience across data management and project management disciplines. Jo has expertise primarily in Clinical Data Management where she has spent over 15 years managing teams of Data Managers and Database Programmers, overseeing the outsourcing of Data Management activities to CROs and of leading EDC implementation projectson Wood has spent nearly 30 years in the drug development industry, working for large pharma/biotech and CROs and has extensive experience across data management and project management disciplines
Location of Course: 12:00 – 13:30 GMT
Learning Objectives:
Who is the Course Suitable For?
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!
This webinar is aimed at Data Managers, Project Managers, Clinical Research Associates, Drug Safety specialists and Quality Assurance personnel
Outline Course Content
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
Link for Booking: click here