Approved by the 91AV for purposes of continuing professional development.
This course will provide you with the requisite scientific knowledge and understanding of analytical method validation, verification and transfer to allow informed interpretation of current regulatory guidance from EMA, FDA and ICH, e.g. Q2(R1).
There are two versions of the course. You can choose between either the ‘Pharmaceutical Analysis’ version (aimed at test methods that are used for small molecules), or the ‘Biopharmaceutical Analysis’ version (aimed at test methods that are used for large molecules). The difference between these alternative versions is that the case studies, real life scenarios, and examples used during the training are tailored to the types of test methods commonly encountered for these different types of molecules. Additionally, advice on regulatory guidance and expectations is relevant to the specific needs of the learner.
Course overview:
The data generated using analytical test methods is essential for many of the critical decisions made in the pharmaceutical industry. To be confident in the integrity of this data it is crucial that the methods are fit for purpose. To demonstrate that a method is fit for purpose will require either a validation, verification or transfer study, depending on the source of the method in question.
This course provides a detailed explanation of how these studies are performed, enabling a full understanding of method performance characteristics and associated statistics, and how they are applied to the techniques used for analysing drug related samples.
Learning Objectives:
The full course takes place over 3 days but if preferred, it is possible to attend the first 2 days only for a method validation course or the last day only for a method transfer and verification course. In the case of attendance on the last day only it is essential that delegates are familiar with validation characteristics since these are used for method transfer and verification
This course will provide you with the requisite scientific knowledge and understanding of analytical method validation, verification and transfer to allow informed interpretation of current regulatory guidance from EMA, FDA and ICH, e.g. Q2(R1).
There are two versions of the course. You can choose between either the ‘Pharmaceutical Analysis’ version (aimed at test methods that are used for small molecules), or the ‘Biopharmaceutical Analysis’ version (aimed at test methods that are used for large molecules). The difference between these alternative versions is that the case studies, real life scenarios, and examples used during the training are tailored to the types of test methods commonly encountered for these different types of molecules. Additionally, advice on regulatory guidance and expectations is relevant to the specific needs of the learner.
Course overview:
The data generated using analytical test methods is essential for many of the critical decisions made in the pharmaceutical industry. To be confident in the integrity of this data it is crucial that the methods are fit for purpose. To demonstrate that a method is fit for purpose will require either a validation, verification or transfer study, depending on the source of the method in question.
This course provides a detailed explanation of how these studies are performed, enabling a full understanding of method performance characteristics and associated statistics, and how they are applied to the techniques used for analysing drug related samples.
Learning Objectives:
- Understand the purpose of analytical method validation and the principles of measurement uncertainty.
- Define the parameters used for method validation, i.e. the validation characteristics as per ICH Q2(R1) of: specificity, accuracy, range, linearity, precision, detection limit, quantitation limit and robustness.
- Generate a validation, verification or transfer protocol, as appropriate, including practically relevant experiments and acceptance criteria.
- Interpret the results of validation, verification and transfer studies using appropriate statistics.
- Understand the different possible approaches that may be used for analytical method transfer as per available guidance from EMA, USP <1224>, FDA and WHO.
- Review analytical procedures in terms of transfer to another laboratory and identify potential problems.
The full course takes place over 3 days but if preferred, it is possible to attend the first 2 days only for a method validation course or the last day only for a method transfer and verification course. In the case of attendance on the last day only it is essential that delegates are familiar with validation characteristics since these are used for method transfer and verification
