FDA 2019 - ASTM 2500: Lessons Learned Through a Decade of Implementation

Overview
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.
One of the most critical factors in manufacturing pharmaceuticals and medical devices is ensuring that equipment used for production is properly validated. Validation is required to demonstrate that equipment is fit for its intended use.
Session Highlights
• Regulatory Requirements for a Compliant Validation Program
o FDA
o EU
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
• What is ASTM 2500
o Definition
o Concept
o Requirements
o Differences from traditional validation approach
• Real World Examples of ASTM 2500 Implementation
o Lessons Learned
Who Will Benefit
Operations
Quality Assurance
Quality Engineering
Validation
Engineering
Speaker:
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, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.