Online Training: Preparing for Regulatory Inspections
£50.00
Preparing for Regulatory Inspections Course.
This course provides an overview of the critical preparation tasks required to ensure your inspection achieves the best possible outcome for your organisation. 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. The learning outcomes for the course are as follows:
Recap on the basics of ICH GCP focusing on the R2 addendum
Gain a knowledge of the cascade of regulations that exist
Understand the responsibilities of the regulatory authorities
Recognise the different types of inspection and what the inspectors inspect against
Understand the general inspection process
Understand what an inspection dossier and inspection plan is
Understand how to assure compliance to regulations
Recognise what you must do to prepare for an inspection
Know how to prepare your work area before the Inspector arrives
Understand how to interact with the Inspector
Recognise some of the typical Data Management findings from inspections
Purchase Individual ACDM Membership and receive a discount on training courses, events and attending the annual conference.
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Online Training: Preparing for Regulatory Inspections
£50.00
Preparing for Regulatory Inspections Course.
This course provides an overview of the critical preparation tasks required to ensure your inspection achieves the best possible outcome for your organisation. 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. The learning outcomes for the course are as follows:
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