Event Detail
Design Validation Protocol and Acceptance Criteria for Chromatographic Methods to meet ICH requirements
March 17, 2010
- Palo Alto CA UNITED STATES
ComplianceOnline
Key validation characteristics of HPLC methods mandated according to cGMP and ICH guidelines and the stress studies must be considered for HPLC method used in pharma Labs. Why Should You Attend : Analytical methods are used to assure the quality of pharmaceutical products and HPLC methods are widely used in R&D and QC laboratories. Validation of these methods is mandated according to cGMP and ICH guidelines. This session will examine validation parameters and stress studies that must be considered for HPLC methods used in pharmaceutical laboratories. We will also go over validation protocol and appropriate acceptance criteria. Areas Covered in the Seminar: * Examine warning letters and observations from lack of method validation. * Understand regulatory requirements for method validations and business drivers for developing a ‘validatable’ method. * Discuss validation parameters for HPLC analyses based on ICH requirements. * Discuss appropriate stress studies for stability indicating methods. * Outline validation protocol and appropriate acceptance criteria. * Discuss the importance of validation by phases of development. * Understand the consequences of validation non-compliance. Learning Objectives: * Upon completion of this session, attendees will understand the key validation characteristics of HPLC methods and the rationale of doing so. * Participants will gain practical knowledge about key parameters considered for method validation. * The course will also discuss observations and infractions that were obtained due to lack of method validation. * Important factors for re-validation will also be covered based on phases of drug development.