Part 2 - Quality Management System effectiveness: ICH Q10 principles, impact of failure on COGS, principles of QRM, what you can impact in reactive versus proactive 2015

Topics

• What ICH Q10 covers, including scope and applicability to the various parts of the operations
• The differences between the old GMP mindset and the new quality systems mindset – and how they both affect our daily operations
• How to assess your own site processes and systems against the guidance
• All of the parts required for an effective quality system (per these guidance and regulations), and how the systems should interact

Who should Attend

Senior Managers/Managers and Leaders in:

• Production and Operations
• Quality Assurance
• Regulatory Affairs
• Product Development
• Labeling
• Marketing/Advertising