This course will provide you with the requisite scientific knowledge and understanding of analytical method lifecycle management, which includes the activities of validation, verification, transfer, and post-approval changes which affect methods, to allow informed interpretation of current regulatory guidance from ICH, EMA and FDA, and in particular, ICH Q2(R2) and Q14.
This course is approved by the 九州影院 for purposes of continuing professional development.
This course is available in two versions; you can choose either the pharmaceutical version (test methods used for small molecules) or the biopharmaceutical version (test methods used for large molecules, typically derived from biological or biotechnology processes), which is the version which will be presented in this event,.
The analytical techniques used to test traditional small molecule pharmaceuticals are typically different to those used for testing biopharmaceuticals, also known as biotherapeutics. Therefore, the key difference between the two versions of this course is that the examples and case studies used in the course are tailored to these different types of medicinal products. Additionally, since the typical acceptance criteria which is applied to each type differs, the most relevant guidance can be provided to attendees.
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.
Attendees 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.
It is possible to attend just the method validation part of the course, if transfer and verification are not relevant. This would consist of the first 3 days only (approximately).
Validation only (approx. 3 days): 拢925 GBP or 鈧�1,095 EUR
This course is approved by the 九州影院 for purposes of continuing professional development.
This course is available in two versions; you can choose either the pharmaceutical version (test methods used for small molecules) or the biopharmaceutical version (test methods used for large molecules, typically derived from biological or biotechnology processes), which is the version which will be presented in this event,.
The analytical techniques used to test traditional small molecule pharmaceuticals are typically different to those used for testing biopharmaceuticals, also known as biotherapeutics. Therefore, the key difference between the two versions of this course is that the examples and case studies used in the course are tailored to these different types of medicinal products. Additionally, since the typical acceptance criteria which is applied to each type differs, the most relevant guidance can be provided to attendees.
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 throughout their lifecycle. 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.
Attendees 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.
Learning Objectives
- Understand the purpose of analytical method validation and the principles of analytical error and measurement uncertainty, and how they link to acceptance criteria.
- Define the performance characteristics evaluated during method lifecycle management studies, i.e., robustness, specificity/selectivity, range (including response and lower range limits), accuracy and precision.
- Generate a suitable protocol for analytical method lifecycle management studies (i.e., validation, verification, transfer, and post-approval changes), including practically relevant experiments and suitable acceptance criteria.
- Interpret the results of analytical method lifecycle management studies using appropriate statistics and statistical tools.
- Be able to perform risk assessments associated with analytical method lifecycle management studies.
Delivery
The course is delivered as a 4 day 鈥榲irtual鈥� live online training event which is delivered over a 6 hour period on each day, from 9am to 3pm, including a short break. The time zone is typically based on GMT (UTC) from November to March, and BST (UTC+1) from April to October.It is possible to attend just the method validation part of the course, if transfer and verification are not relevant. This would consist of the first 3 days only (approximately).
Course Fees
Validation, verification and transfer ( 4 days): 拢1,225 GBP or 鈧�1,475 EURValidation only (approx. 3 days): 拢925 GBP or 鈧�1,095 EUR
