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Quality Assurance and Quality Management Concepts: Definition and concept of quality control, quality assurance and GMP.
Total Quality Management (TQM): Definition, elements, philosophies.
ICH Guidelines: Purpose, participants, process of harmonization. Brief overview of QSEM with special emphasis on Q series guidelines, ICH stability testing guidelines.
Quality by Design (QbD): Definition, overview, elements of QbD program, tools.
ISO 9000 and ISO 14000: Overview, benefits, elements, steps for registration.
NABL Accreditation: Principles and procedure.

Organization and Personnel: Personnel responsibilities, training, hygiene and personal records.
Premises: Design, construction and plant layout, maintenance, sanitation, environmental control, utilities and maintenance of sterile areas, control of contamination.
Equipments and Raw Materials: Equipment selection, purchase specifications, maintenance, purchase specifications and maintenance of stores for raw materials.

Quality Control: Quality control test for containers, rubber closures and secondary packing materials.
Good Laboratory Practices: General provisions, organization and personnel, facilities, equipment. Testing facilities operation, test and control articles, protocol for conduct of a non-clinical laboratory study, records and reports, disqualification of testing facilities.

Complaints: Complaints and evaluation of complaints, handling of returned goods, recalling and waste disposal.
Document Maintenance in Pharmaceutical Industry: Batch formula record, master formula record, SOP, quality audit, quality review and quality documentation, reports and documents, distribution records.

Calibration and Validation: Introduction, definition and general principles of calibration, qualification and validation, importance and scope of validation, types of validation, validation master plan. Calibration of pH meter, qualification of UV-Visible spectrophotometer, general principles of analytical method validation.
Warehousing: Good warehousing practice, material management.