This one-day training is intended to provide participants with an overview of all aspects that are critical to the proper functioning of change management through Change Control.
Every company experiences changes from time to time. These changes are often known in advance, such as new equipment, renovations, and modifications to the product range. At other times, changes occur unexpectedly and are only recognized retrospectively, such as procedures that are not properly followed in practice.
The greatest risk associated with changes is that they may have an adverse effect on product quality — and to a lesser extent, on the smooth operation of your QMS, equipment, or process.
For this reason, GMP and GDP regulations require pharmaceutical companies to have systems in place to manage such changes, commonly referred to as Change Control.
In this context, it is essential that a change may only be accepted after documented investigation has shown that it has not affected product quality and does not conflict with general GMP/GDP principles. In recent years, authorities have paid considerable attention to these systems during GMP/GDP inspections.
Many of the deficiencies noted by the authorities can be traced back to the fact that these systems do not function adequately.
Moreover, by addressing changes and deviations properly, quickly, and effectively, significant improvements can be achieved in product quality, as well as considerable savings in time and resources.
