Course Scope:
It has been recognised for many years that the sampling and testing of materials does not by itself assure product quality. Any testing performed must be part of a comprehensive 鈥楶harmaceutical Quality System鈥�, including QA and GMP, and it must be correctly implemented and controlled.
This module reviews the principal qualitative and quantitative analytical methods in common use, the principles of method selection and validation. It also includes, sampling plans, physical and organoleptic testing, stability testing and the significance of degradation, contamination and adulteration of pharmaceutical materials.
Importantly, it also includes the interpretation of analytical data including non conforming results and stresses the importance of how these need to be managed. All activities are discussed and explained within the confines of current Good Quality Control Laboratory Practice and applicable regulatory guidelines.
Overview:
At the end of the course you will:
鈥nderstand the principal analytical methods in common use in a Pharmaceutical QC laboratory
鈥ave confidence interpreting analytical data and dealing with non conforming results
鈥nderstand the principles of method selection and validation
鈥e aware of current stability testing requirements and management of stability testing programmes
鈥e aware of current EU guidelines relating to analysis and testing
Who should attend:
This module forms part of a series designed to satisfy the Study Guide requirements for those wishing to become a QP. It is also suitable for any analysts who 鈥渓eft the laboratory鈥� a long time ago and other production and QA professionals wishing to top up their knowledge and current understanding of QC laboratory expectations as part of their Continuing Professional Development (CPD).
It has been recognised for many years that the sampling and testing of materials does not by itself assure product quality. Any testing performed must be part of a comprehensive 鈥楶harmaceutical Quality System鈥�, including QA and GMP, and it must be correctly implemented and controlled.
This module reviews the principal qualitative and quantitative analytical methods in common use, the principles of method selection and validation. It also includes, sampling plans, physical and organoleptic testing, stability testing and the significance of degradation, contamination and adulteration of pharmaceutical materials.
Importantly, it also includes the interpretation of analytical data including non conforming results and stresses the importance of how these need to be managed. All activities are discussed and explained within the confines of current Good Quality Control Laboratory Practice and applicable regulatory guidelines.
Overview:
At the end of the course you will:
鈥nderstand the principal analytical methods in common use in a Pharmaceutical QC laboratory
鈥ave confidence interpreting analytical data and dealing with non conforming results
鈥nderstand the principles of method selection and validation
鈥e aware of current stability testing requirements and management of stability testing programmes
鈥e aware of current EU guidelines relating to analysis and testing
Who should attend:
This module forms part of a series designed to satisfy the Study Guide requirements for those wishing to become a QP. It is also suitable for any analysts who 鈥渓eft the laboratory鈥� a long time ago and other production and QA professionals wishing to top up their knowledge and current understanding of QC laboratory expectations as part of their Continuing Professional Development (CPD).
