Why the course “Method validation – structure and design under ISO/GMP/GLP “?
What is involved in validating a method? That is the subject of this course. Modern quality management systems for control laboratories (such as, for example: ISO 17025, ISO 15189 and GLP/GMP), require working with validated analysis and testing methods. However, the quality standards do not describe how analysis and test methods can be validated.
In this course, you will learn how to set up validations according to the ICH guideline. Upon completion, you will have a clear understanding of the validation of analysis and test methods and will be able to set up and execute a validation plan for the methods in your own laboratory. Optionally, you can attend the additional day that deals specifically with HPLC methods. This course is closely related to the course Practical Statistics with Excel 2: for Method Validation, but can also be taken separately.
Who is this course designed for?
You have at least a college education or you are a college graduate with extensive experience. You are directly or indirectly involved in method validation and you want to know more about setting up and executing validation plans, collecting the necessary information and documenting validations.
The following topics will be covered over two days.
- Introduction and basic principle standards (including GMP / ISO)
- Validation, qualification and calibration
- Quality Management Systems
- Analytical Method Validation
- Equipment Qualification
- Further development
In this course you will learn which aspects to pay attention to in validation and which not. With this knowledge you will prepare in workshops a validation plan of a simple test case or of your own method. The draft plans are evaluated and adjusted during the course. With the new insights gained, you can then validate the methods in your own practice. This course is closely related to the course Practical Statistics with Excel for Method Validation, but can also be taken separately.
Upon completion of this course, you will have a clear understanding of the various validation models. You will be able to set up and execute a validation plan, with appropriate documentation for each phase.
After successful completion of the course, you will receive a certificate of participation.
Date & investment
The course consists of a total of two days: Oct. 27 and Nov. 3.
The investment for the course is as follows:
Course fee: €1,290 (excluding 21% VAT).
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