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

CGMP Quality Principles for the FDA Regulated Industries: 2-Day In-Person Seminar covers topics such as:

  • 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

CGMP Quality Principles for the FDA Regulated Industries: 2-Day In-Person Seminar brings together attendees from all levels of quality, regulatory, and technical experience who work in a Current Good Manufacturing Practices (CGMP) environment.

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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