CGMP Quality Principles for the FDA Regulated Industries: 2-Day In-Person Seminar 2016

Topics

• Guidance on how cGMPs apply to their role and responsibilities and how to apply these principles in their daily activities
• GMP concepts to decision making in a managerial role
• ICH and IMDRF(GHTF) and harmonization documents and the perspective of how they may be applied to [[ achieve ]] compliance and improve products and processes to achieve greater customer satisfaction
• Better manage quality, solve problems, and make improvements
• The relationships of all the CGMPs to other FDA regulations and to the medical products life cycles
• The similarities and differences between the FDA`s GMP Quality Systems for Active Pharmaceutical Ingredients (Q7A), Drug Product (Part 210/211), Biologicals (Part 600-680) and Medical Devices (Part 820 ISO 13485)
• The current compliance hot spots that FDA and international authorities look for when inspecting for CGMP compliance
• International cGMP regulations
• How to better locate regulatory information and to interpret , assess , and make decisions concerning GMP issues

Who should Attend

Attendees from all levels of quality, regulatory, and technical experience who work in a Current Good Manufacturing Practices (CGMP) environment.