The current concepts of Quality

  The relationship between Demming, Juran ,Cosby , Feginbaum, Isikhawa and Taquichi and the current concepts of Quality, QA , QC and GMP in the Pharmaceutical Industry  critically evaluate current and proposed legislation and regulation guiding how to implement systems within the pharmaceutical industry to ensure compliance with regulatory requirements  prescribe regulatory requirements for submission to authorities in EU / US / Japan  critically evaluate various the licensing route in the EU and develop a strategy for the most efficient procedures  critique the role of the European Directorate for the quality of pharmaceutical products.  research, evaluate and synthesize information and present it in the required written format for regulatory submissions  critically assess theFDA /EU Regulatory compliance requirements for pharmaceutical products  utilise FDA Regs/EU directives to determine regulatory compliance regime across several product sectors.