Meet the Tougher U.S. FDA CGMPs 2018

Topics

• Avoid complacency from past "good" U.S. FDA/ EU ISO audits
• The "targets"
• Proactive responses -- where to shift focus first
• The basic underlying issues
• A risk-based phased approach
• Where to direct scarce resources
• Maintain `the edge`
• Avoid `entropy` -- Prove `in control`

Who should Attend

• Senior management
• Quality Assurance
• Regulatory Affairs
• Engineering
• Production
• Internal Audit
• Documentation
• All personnel involved in a U.S. FDA-regulated environment, especially those involved in regulatory compliance, CGMP training and auditing, and the production and documentation of regulated medical products.