Validation of Analytical Methods for Pharmaceutical Analysis
Training
In Berlin (Germany), City Of London and Dublin (Ireland)
Description
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Type
Training
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Level
Intermediate
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Location
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Duration
2 Days
This 2 day course provides a detailed description of how analytical methods are validated, enabling a full understanding of method performance characteristics and associated statistics and how they are applied. This knowledge will enable informed interpretation of the regulatory guidance on validation, namely ICH Q2(R1).
Facilities
Location
Start date
Start date
Start date
Start date
About this course
After attending this course you will be able to:
Understand the purpose of analytical method validation.
Define the parameters used for method validation; ie. validation characteristics.
Generate a validation protocol including relevent acceptance criteria.
interpret the results of validation using appropriate statistics.
Anyone who needs to understand how methods are validated, either to design and carry out the investigation or to interpet the data generated; Analytical chemists, QA/RA managers laboratory managers/supervisors, QC analysts/managers, students.
This course is suitable for:
Anyone who needs to understand how methods are validated, 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, and regulatory affairs managers.
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www.mournetrainingservices.co.uk
There you will find clear and easy to find instructions on how to enrol on any of our excellent courses.
Reviews
Subjects
- Either to design and carry out the investigation
- Laboratory managers/supervisors
- Quality control analysts/managers
- Quality assurance managers
- And regulatory affairs managers
Teachers and trainers (1)
Oona McPolin
Training consultant
Training consultant specialising in analytical chemistry relating to pharmaceuticals; design and deliver training courses including validation and transfer of analytical methods and high performance liquid chromatography (HPLC). Analytical chemist with over 17 years' experience in pharmaceutical analysis; developing, validating and implementing analytical methods in process and formulation, stability, forced degradation, regulatory submissions. · Fully qualified award winning trainer in design and delivery of effective training for technical subjects.
Course programme
The data generated using analytical methods is essential for many of the critical decisions made in the pharmaceutical industry. To be confident in the reliability of this data it is crucial that the methods are fit for purpose. Analytical method validation is the process of demonstrating that a method is suitable for its intended use.
The approach of this course is to focus on the principles of method validation 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).
Included:
Comprehensive course handouts; Certificate of Attendance; access to training resources via e-MTS; optional post training assessment (leading to Certificate of Training); post training support; and a copy of the MTS training book, Validation of Analytical Methods for Pharmaceutical Analysis. Lunch and refreshments are included for open enrolment training courses.
Additional information
Validation of Analytical Methods for Pharmaceutical Analysis