Overview: Pharmaceutical products are ultimately released to the consumer based on a certificate analysis generated by laboratory testing.

It is critical the results obtained from these methods reflect the true identity, strength and purity of the product. So how can we trust these results? Method validation is the process which we use to document and prove the reliability, consistency and accuracy of the analytical results. Although the regulations, requirements and guidelines for validation are now globally harmonized and guidelines exist in black and white, the practical execution of validation studies still give rise to many problems since requirements of methods tend to require attention on a case to case basis which often fall into "grey areas". This webinar reviews the fundamentals of HPLC method validation in the Pharmaceutical industry and describes an approach which will give you the tools to enable you to determine a validation study for your methods using current guidelines. It redefines the purpose of analytical performance characteristics, describes how to determine the end use of the method and select realistic acceptance criteria. The approach is substantiated by a hands on exercise to be completed along with the instructor. Content of a validation protocol and report are also discussed.

Why you should attend: Are you over validating your methods? Do you have problems selecting meaningful accetpance criteria? Are you new to method validation or just want a refresher course? Do the current guidelines not give enough detail for your needs? If your answer is yes to any of the above then this webinar is for you.

Areas Covered in the Session:

* The purpose of method validation
* Analytical performance characteristics and their role
* Preparing for method validation
* The prevalidation phase
* Determining the end use of the method
* Selecting appropriate validation parameters and acceptance criteria
* Interpreting the guidelines
* Documentation: The protocol and report
* When revalidation of methods is required

Who Will Benefit:

* Laboratory Analysts
* Validation Specialists
* Quality Assurance staff
* Regulatory Affairs staff
* Consultants
* Analysts and other laboratory staff
* Training Departments