Meet the Tougher U.S. FDA CGMPs
June 4, 2013 - Palo Alto CA US
Areas Covered in the Seminar: The "targets". Avoid complacency from past "good" U.S. FDA/ EU ISO audits. The basic underlying issues Proactive responses -- where to shift focus first Where to direct scarce resources A risk-based phased approach Avoid 'entropy' -- Prove 'in control' Maintain 'the edge' Who Will Benefit: This training will benefit personnel/ companies in the pharmaceutical, medical device, diagnostic, nutraceuticals and biologics fields. The employees who will benefit include: Senior management Regulatory Affairs Quality Assurance Production Engineering Documentation Internal Audit 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.