An intensive short course in the validation of high performance liquid chromatography (HPLC) methods
Why to approach validation as part of a larger process
What the important regulatory documents are
What parameters of the method need to be tested
What is Quality by Design and why is it important
What software tools are available to simplify the process
Are there pitfalls that I should avoid in validation
What is pre-validation and why is it worth my time
How do I choose a system suitability sample
How can I tell if the method is out of control
What will I get from this course?
You will understand how to organise a validation project. By planning ahead, you will see how to develop better methods that will validate more easily and will function more reliably in routine use. You will learn how to decide which variables are important and which ones are not. You will see how software tools can help you. You will gain a better understanding of the calibration process and how to examine data for problems. You will also learn when method adjustments are allowed without re-validating the method and find out why uncertainty plays such a big role in validation.
Method development and pre-validation
Validation and documentation
Quality by Design and robustness testing
Data analysis
Available as an in-house or off-site course.
Who should take this course?
This course is designed for laboratory personnel responsible for validating HPLC methods. It will also be useful for managers and quality assurance staff involved in the method validation process. For workers who develop, but do not validate methods, this class will give insight into how to develop methods that will be easier to validate. Those with some laboratory experience will benefit from this course more than those with no experienceWhat does it cover?
This one day course focuses on validating HPLC methods developed for the analysis of pharmaceutical drug substances (pure drugs), drug products (formulated drugs), impurities and degradation products. Although the focus is on pharmaceuticals, the principles apply for most quantitative HPLC methods. This course, designed by validation expert Dr Shib Mookherjea, will teach you how to avoid expensive validation problems and how to take advantage of the information provided by a well-designed, well-implemented validation. This course includes:Why to approach validation as part of a larger process
What the important regulatory documents are
What parameters of the method need to be tested
What is Quality by Design and why is it important
What software tools are available to simplify the process
Are there pitfalls that I should avoid in validation
What is pre-validation and why is it worth my time
How do I choose a system suitability sample
How can I tell if the method is out of control
What will I get from this course?
You will understand how to organise a validation project. By planning ahead, you will see how to develop better methods that will validate more easily and will function more reliably in routine use. You will learn how to decide which variables are important and which ones are not. You will see how software tools can help you. You will gain a better understanding of the calibration process and how to examine data for problems. You will also learn when method adjustments are allowed without re-validating the method and find out why uncertainty plays such a big role in validation.
Course Outline
Introduction to validationMethod development and pre-validation
Validation and documentation
Quality by Design and robustness testing
Data analysis
Available as an in-house or off-site course.
