Quality Metrics Program: FDA Challenges and Requirements including the New `Quality Metrics Technical Conformation Guide` Released June 2016

Topics

• What are Quality Metrics
• FDA interest in Quality Metrics
• Data that is required by the industry
• Quality metrics parameters FDA will request
• The reporting format for the Quality Metrics
• The meaning of each of the quality metrics
• Suggestions on how the firm can use the metrics to proactively support continuous improvement
• The impact of the FDA expectations on the pharmaceutical firm
• What is ahead
• An outsider`s prospective

Who should Attend

• Quality Control - all levels
• Quality Assurance - all levels
• Senior corporate management
• Operations - site management
• Auditors - all levels