Executive Development Programme: Pharmaceutical Quality Assurance
-- ViewingNowThe Executive Development Programme: Pharmaceutical Quality Assurance certificate course is a comprehensive training program designed to meet the growing industry demand for skilled professionals in pharmaceutical quality assurance. This course emphasizes the importance of implementing and maintaining quality systems in pharmaceutical manufacturing, ensuring compliance with regulatory standards, and fostering continuous improvement.
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โข Quality Management Systems (QMS) in Pharmaceutical Industry: Overview, ISO standards, FDA regulations, Quality Manual, SOPs, and QMS implementation
โข Pharmaceutical Good Manufacturing Practices (GMPs): CGMP regulations, GMP for APIs, GMP for finished pharmaceuticals, and GMP for medical devices
โข Quality Risk Management (QRM): ICH Q9, Risk identification, assessment, and mitigation, and QRM tools and techniques
โข Quality Control (QC) and Quality Assurance (QA): QC vs QA, QC testing, QC release, QA review, and QA oversight
โข Change Management: Change control process, change request, and change implementation
โข Complaint Handling and Root Cause Analysis (RCA): Complaint intake, investigation, and RCA techniques
โข Auditing and Inspection Preparedness: Internal audits, supplier audits, and inspection readiness
โข Regulatory Affairs and Submissions: Regulatory strategy, submission types, and eCTD format
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