To convey a clear understanding of regulatory agency expectations and knowledge of the elements of an effective validation program. Students will gain expertise in writing protocols and reports and developing acceptance limits for assay validation. This course provides insight on how to avoid conflict validation pitfalls and ability to distinguish compliant from non-compliant validation activities.
One of the most critical factors in developing pharmaceutical drug substances and drug products today is ensuring that the analytical methods that are used to analyze the products generate meaningful data. The FDA, USP, and the ICH have each recognized the importance of analytical method validation to the drug development process and have increased method validation requirements in recent years.
Both the theoretical basis and practical applications of the validation process will be discussed. Some of the more common mathematical and statistical treatments of validation data will be presented. Because of the tremendous effort that can be expended in conducting validation studies, efficiency of experimental design and documentation will be stressed throughout the discussions and case studies.
• Method Validation Background
• ICH/USP Validation Requirements
• Acceptance Criteria
• Method Validation vs. Method Purpose
• Method Validation Overview
• Method Validation Process and Statistics
• Bio-Analytical Method Validation
• Method Transfer Process
• Revalidation and Method Update
• Technology Changes
• Protocols /reports and Related Documents
Upon completion of this course the attendees will be able to:
1. Gain an overview of the background and history of method validations
2. Gain an understanding of method validation requirements per ICH and US Pharmacopoeia (USP), such as the classification of methods (e.g. assay, identity) and various characterizations (e.g. accuracy, precision, specificity, etc.)
3. Gain an understanding of how to define the acceptance criteria, including discussions on USP references, process and statistical techniques.
4. Gain an understanding of analytical method transfer requirements, that is, transferring a validated method between sites.
5. Gain an understanding of bioanalytical method validation based on the FDA guidance
6. Gain an understanding of the regulatory resources that relate to method validations, transfers, and related requirements
Fees & Funding
Please enquire below for course fees and financial grants: