Quality is not an Organization 2017

Topics

• Lessons Learned from 483s and Warning Letters
• FDA and NB expectations for Quality Systems
• Management Commitment and Responsibility
• How Culture can Impact Quality and Compliance Risk
• Key Capabilities
• Maturity Modeling
• Quality Planning and Strategy
• Roles and Responsibilities
• Best Practices
• Tools and Techniques

Who should Attend

• Internal Auditors and Managers
• Quality and Compliance Specialists
• CAPA Specialists
• Training Specialists