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:
1. Understand the purpose of analytical method validation and the principles of measurement uncertainty.
2. 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.
3. Generate a validation, verification or transfer protocol, as appropriate, including practically relevant experiments and acceptance criteria.
4. Interpret the results of validation, verification and transfer studies using appropriate statistics.
5. Understand the different possible approaches that may be used for analytical method transfer as per available guidance from EMA, USP <1224>, FDA and WHO.
6. Review analytical procedures in terms of transfer to another laboratory and identify potential problems.
Delivery options for this course:
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.
The courses are available throughout the year, refer to the MTS website for full details.
Use of case studies and real life scenarios:
The approach of this course is to focus on the principles of method validation, verification and transfer, thereby enabling application to different types of samples and analytical techniques. Case studies are employed to allow consideration of real life scenarios. Examples relating to small molecule drug substances and formulated products, and to physiochemical methods for biotechnological/ biological products, are included. Particular attention is paid to the most common analytical techniques used for pharmaceutical analysis, e.g., High Performance Liquid Chromatography (HPLC).
Delegates are invited to bring along any real life examples that they would like advice on during the training. These may be discussed during group exercises, or, where intellectual property is an issue, privately with the trainer.
This course is suitable for:
Anyone who needs to understand how methods are validated, verified or transferred, either to design and carry out the investigation, or to interpret the data generated.
For example:
• Analytical chemists;
• Laboratory managers/ supervisors;
• Quality control analysts/ managers;
• Quality assurance managers;
• Regulatory affairs managers;
• etc.
Included in the course fees:
• Comprehensive course hand-outs;
• Certificate of Attendance;
• Access to training resources via e-MTS;
• Optional post training assessment (leading to Certificate of Training);
• Post training support;
• A copy of the MTS training book, Validation of Analytical Methods for Pharmaceutical Analysis;
• Lunch and refreshments (for open-enrolment courses only).
Course agenda & outline can be found by clicking on the 'More information' button.
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:
1. Understand the purpose of analytical method validation and the principles of measurement uncertainty.
2. 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.
3. Generate a validation, verification or transfer protocol, as appropriate, including practically relevant experiments and acceptance criteria.
4. Interpret the results of validation, verification and transfer studies using appropriate statistics.
5. Understand the different possible approaches that may be used for analytical method transfer as per available guidance from EMA, USP <1224>, FDA and WHO.
6. Review analytical procedures in terms of transfer to another laboratory and identify potential problems.
Delivery options for this course:
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.
The courses are available throughout the year, refer to the MTS website for full details.
Use of case studies and real life scenarios:
The approach of this course is to focus on the principles of method validation, verification and transfer, thereby enabling application to different types of samples and analytical techniques. Case studies are employed to allow consideration of real life scenarios. Examples relating to small molecule drug substances and formulated products, and to physiochemical methods for biotechnological/ biological products, are included. Particular attention is paid to the most common analytical techniques used for pharmaceutical analysis, e.g., High Performance Liquid Chromatography (HPLC).
Delegates are invited to bring along any real life examples that they would like advice on during the training. These may be discussed during group exercises, or, where intellectual property is an issue, privately with the trainer.
This course is suitable for:
Anyone who needs to understand how methods are validated, verified or transferred, either to design and carry out the investigation, or to interpret the data generated.
For example:
• Analytical chemists;
• Laboratory managers/ supervisors;
• Quality control analysts/ managers;
• Quality assurance managers;
• Regulatory affairs managers;
• etc.
Included in the course fees:
• Comprehensive course hand-outs;
• Certificate of Attendance;
• Access to training resources via e-MTS;
• Optional post training assessment (leading to Certificate of Training);
• Post training support;
• A copy of the MTS training book, Validation of Analytical Methods for Pharmaceutical Analysis;
• Lunch and refreshments (for open-enrolment courses only).
Course agenda & outline can be found by clicking on the 'More information' button.
