o ICH Q7
o ICH Q8: Pharmaceutical Development
o ICH Q9: Quality Risk Management
o Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach
o Differences from traditional validation approach
o Lessons Learned
One of the most critical factors in manufacturing pharmaceuticals and medical devices is ensuring that the equipment used for production is properly validated. Validation is required to demonstrate that equipment is fit for its intended use. Regulatory bodies; such as the FDA and EMEA place a high level of scrutiny on a firm’s validation program during GMP compliance inspections. Therefore, it is essential to an organization’s success to implement a robust, compliant validation approach.
In recent years, there have been several standards and guidance documents created to discuss best practices for commissioning, qualification, and validation. One of these documents is the ASTM E2500 standard guide. Unfortunately, some of these documents are too vague and lack the details needed to provide adequate guidance and direction to the industry. This webinar discusses the concepts found in ASTM E2500 in sufficient detail to help industry professionals understand how to implement a validation program based on the ASTM 2500 approach.
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.