QUALITY ASSURANCE (QA) DEPARTMENT – SYLLABUS.

QUALITY ASSURANCE (QA) DEPARTMENT – SYLLABUS :

  • Good Manufacturing Practice (GMP) , D & C Act – Schedule M .
  • Good Laboratory Practices (GLP) , D & C Act – Schedule L1
  • Role of Quality Assurance Department in Pharmaceutical Organizations  & 10 Principles of GMP.
  • Quality Management System (QMS)
  • Fundamentals of Standard Operating Procedures (SOPs) ,SOP

    Index/List & QA SOPs.

  • Good Documentation Practice (GDP).
  • QA In-process (IPQA) Checks on Pharmaceutical Organization.
  • Internal audits / Self Inspection / External Audits & Vendor Audit.
  • Change Control & Deviations
  • Site Master File (SMF).
  • Market complaint Investigations, evaluation & Corrective And Preventive Actions (CAPA).
  • How to face interview in Pharmaceutical organizations.
  • Important likely questions asked during interview in pharmaceutical

         Organizations.

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