Corrective and Preventive Action – is the CAPA closed?

Corrective and Preventive Action (CAPA) is a key process within a pharmaceutical quality management system. It is the process of identifying and documenting corrections and improvements to systems and processes to reduce the risk of a deviation, non-conformance or …


Data Integrity: A hot topic in FDA Warning Letters

Data integrity continues to be a focus during US FDA inspections. A number of warning letters issued by the FDA in 2022 highlight the importance of Data Integrity compliance.
In the warning letters issued, the FDA references the FDA’s guidance …


Job Seeker Education Options: Microlearning Options

Microlearning can boost your chances of getting an interview when changing careers. Find out how 1-day intensive education courses & GMP eLearning courses can help you (and other job seekers) gain interviews in an unfamiliar industry.
2023 Careers: Job Seeker …


Clinical Evaluation EU-MDR requirements

Clinical Evaluation EU-MDR requirements 
This article provides a brief overview of Clinical Evaluation requirements as described in the European Medical Device Regulation – EU MDR . 
What is meant by the term ‘clinical evaluation’ in the EU MDR? 
The EU Medical Device …