During this Education Course you will learn how the various pharmaceutical quality and documentation systems work and how they interact. Experts from the pharmaceutical industry will show you possibilities to improve your systems and how to run them efficiently and in compliance with (c)GMP.
Pharmaceutical Quality Assurance and GMP Compliance Managers are continuously facing new challenges due to changing regulatory requirements and at the same time increasing needs for efficiency.
In this context, GMP-Compliance Managers must be familiar with many GMP-related topics, such as:
Knowledge and interpretation of Regulatory Requirements and Expectations
Deviations and Failure Investigation
Batch Record Review
PQR / APR
Risk Analysis and Assessment
These are not stand alone systems. They are all linked to each other: A Deviation causes a Failure Investigation which is followed by a CAPA that can lead to a Change and Change Control. And all relevant information must be documented in the PQR and APR.
Companies should have all these systems in place. Let's find out how we can get the most out of them!