25 June, 2012
The Dorsett Hotel, Kuala Lumpur, Malaysia
Price: US$ 795
A short course in the validation of high performance
liquid chromatography(HPLC) methods.
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. No prior experience is needed, although those with some laboratory experience will certainly benefit more than those with no experience at all.
What does it cover?
This one-day class focuses on validating HPLC methods developed for the analysis of pharmaceutical drug substance (pure drugs), drug product (formulated drugs), impurities, and degradation products. It does not focus on bioanalytical methods (drugs in plasma or tissue) – for these, see our Bioanalytical LC-MS/MS class. Although the focus is on pharmaceuticals, the principles apply for most quantitative HPLC methods.
• Why to approach validation as part of a larger process
• Learn the important regulatory documents
• 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 organize 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 to get much more mileage out of your experimental runs. You will gain a better understanding of the calibration process and how to examine data for problems. Learn when method adjustments are allowed without re-validating the method. Find out why uncertainty plays such a big role in validation.
Course Outline
Section 1. Introduction to Validation
What is validation and why do we do it
Steps in validation
Basic HPLC measurements
Validation terms
Section 2. Method Development and Pre-Validation
The importance of a plan
Pre-validation activities
System suitability
Section 3. Validation and Documentation
Steps in validation
Regulatory requirements
Validation reports
Section 4. Quality by Design and Robustness Testing Quality by Design
Robustness testing strategies
Design space and contour plots
Establishing the system suitability test
Section 5. Data Analysis
Calibration methods
Sources of uncertainty
Integration and peak measurement
Control charts
Method adjustment vs. method modification.
Improving precision
Method adjustment vs. method change