GxPs-Good Manufacturing Practice; Applied

This introductory session spells out all the fundamental concepts, practices, and regulations (local/global) of c/GMP in an applied way. The 5 Ps of c/GMP will layout the people (personnel, qualification, required expertise including that pertaining to GEP,GMP,GLP,GPP), premise (utility systems, equipment & requirements, calibrations & qualification, validations(CV)), procedure (policies, guidelines, deviations, validation, contracted parties and good documentation habits), process (development, principles, audits, validations (PV, MVP), standards, value vs supply chain), product (quality assurance &management with systems, specifications/ identifiers, templates, inspections, release, risk management (including CAPA) etc.), for assistants, scientists and pharmacists as appropriate. Explore master BMR and BPR documents. Base and current technologies (key vs supportive) as well as systems are discussed. Submit your homework + assessment for evaluation and obtain your masterclass certificate once successful! Submit your homework and assessment for evaluation and obtain your masterclass certificate once successful!