COURSE OUTLINE:

The reliability of analytical data is critically depended on the validity of the analytical methods and the reliability of the instruments used in the experiments. A systematic approach is required for instrument qualification and performance verification to ensure that instruments perform as intended for their applications. The analytical methods used in drug product development and qualify control applications have to validated for their intended purpose to meet the regulatory requirements.

This course provides the information you need to meet validation compliance within your organization. By attending, you and your company will obtain these key benefits:

• Know validation and instrument qualification concepts, requirements and key terminology.
• Understand regulatory expectations for analytical validation and gain the ICH perspective.
• Assess the impact of validation in your pharmaceutical or biotechnology lab.
• Develop a laboratory equipment and test method validation program, including protocols, procedures and reports, and recognize opportunities to streamline the validation procedure.
• Assure proper validation and transfer of analytical methods per FDA requirements.
• Discern validation requirements of compendial vs. non compendial methods.
• Deal with method adjustments after the method has been validated.
• Understand the impact of instrument performance on method validation