The latest FDA and EMA hot area for citations, warning letters and other actions

This training will provide valuable assistance on how to avoid costly regulatory action from agencies when they inspect your facilities in pharmaceutical and biotech industries. It will show you how to assess your systems and bring them into compliance.

Areas Covered in the seminar:

The various types of deviations, discrepancies, Out of Specification and Out of Trends, action limits and alerts.
The impact of these excursions on your operations and product.
To identify the lightning rods that will lead the inspector to scrutinize your reports and investigations.
To differentiate planned and unplanned deviations and manage them appropriately to your advantage.
The tools of the investigation process and how much investigation is too much.
How to establish good documentation practices in investigations and CAPA?
To tie investigation results into operations and dispositioning materials.
How to write a good CAPA and then track progress and effectiveness.
To know when an investigation and CAPA are completed.
Where a good CAPA system can be used in other systems.

NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.