Validation & Transfer of Methods for Biopharmaceutical Analysis
Approved by the Royal Society of Chemistry 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 ICH, EMA and FDA. The content will also prepare you for the expected changes in regulatory expectations, in particular, the update of ICH Q2(R1).
This course is available in two versions, choose from 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).
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 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. 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.
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.
Open-enrolment training courses:
You can attend one of our open enrolment training courses at the following locations:
Hilton Garden Inn Heathrow, London, UK;
Metro Hotel Dublin Airport, Dublin, Ireland; and
GLS Campus Berlin, Germany.
The courses are available throughout the year, refer to the MTS website for full details.
On-site training courses:
We can deliver the course at your site including any required customisation to meet your specific requirements. Contact us to discuss your training needs and for a quotation.
Use of case studies and real life scenarios:
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
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;
Lunch and refreshments (for open-enrolment courses only).
Approved by the Royal Society of Chemistry 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 ICH, EMA and FDA. The content will also prepare you for the expected changes in regulatory expectations, in particular, the update of ICH Q2(R1).
This course is available in two versions, choose from 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).
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 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. 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.
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.
Open-enrolment training courses:
You can attend one of our open enrolment training courses at the following locations:
Hilton Garden Inn Heathrow, London, UK;
Metro Hotel Dublin Airport, Dublin, Ireland; and
GLS Campus Berlin, Germany.
The courses are available throughout the year, refer to the MTS website for full details.
On-site training courses:
We can deliver the course at your site including any required customisation to meet your specific requirements. Contact us to discuss your training needs and for a quotation.
Use of case studies and real life scenarios:
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
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;
Lunch and refreshments (for open-enrolment courses only).
