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 ICH, EMA and FDA, including the draft revision of ICH Q2 (R2).
The course is available in two versions. This version is the 'Biopharmaceutical Analysis' version, which is aimed at test methods used for large molecules, typically derived from biological or biotechnology processes. (Note: A 'Pharmaceutical Analysis' version is also available, which is aimed at test methods used for small molecules ).
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.
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
The course is delivered as a 4 day, ‘virtual’ 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 (approximately) only for the live online option.
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 review and interpret the data generated. For example:
Validation, verification and transfer ( 4 days): £1,225 GBP or €1,475 EUR
Validation only (approx. 3 days): £890 GBP or €1,050 EUR
Includes:
The course is available in two versions. This version is the 'Biopharmaceutical Analysis' version, which is aimed at test methods used for large molecules, typically derived from biological or biotechnology processes. (Note: A 'Pharmaceutical Analysis' version is also available, which is aimed at test methods used for small molecules ).
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.
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, the principles of analytical error and measurement uncertainty, and how they link to acceptance criteria.
- Define the parameters used for method validation, i.e., the validation characteristics as per ICH Q2 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 verification and transfer as per available guidance.
- Review analytical procedures in terms of verification and transfer and identify potential problems.
The course is delivered as a 4 day, ‘virtual’ 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 (approximately) only for the live online option.
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 review and interpret the data generated. For example:
- Development/Quality Control (QC) analytical chemists
- Development/Quality Control (QC) managers/ supervisors
- Quality Assurance personnel
- Regulatory affairs personnel
Validation, verification and transfer ( 4 days): £1,225 GBP or €1,475 EUR
Validation only (approx. 3 days): £890 GBP or €1,050 EUR
Includes:
- Comprehensive course hand-outs - The training book is provided as an electronic copy (pdf), which is provided in advance.
- Certificate of Attendance
- Optional post training assessment (accessed in e-MTS, our learning management system) which leads to a Certificate of Training.
- Access to training materials via e-MTS
- Post training support – Attendees can contact the trainer with questions that may occur when they apply their learning to real life situations.
