UNIT 1:
Introduction: QC, QA, and GMP
Total Quality Management (TQM): Elements and Philosophies
ICH Guidelines: Purpose, Participants, Harmonization
Quality by Design (QbD): Overview, Elements, Tools
ISO 9000 & ISO 14000: Overview, Benefits, Registration Steps
NABL Accreditation: Principles and Procedures
UNIT 2:
Organization & Personnel: Roles, Responsibilities, Training
Personnel Hygiene and Personal Records
Premises: Design, Construction, Plant Layout
Equipment Selection, Purchase, and Maintenance
Raw Materials: Purchase, Storage, and Maintenance of Stores
UNIT 3:
Complaints: Types, Evaluation, and Handling
Complaints: Types, Evaluation, and Handling
Complaints: Types, Evaluation, and Handling
Complaints: Types, Evaluation, and Handling
Handling of Returned Goods
Handling of Returned Goods
UNIT 4:
SOPs, Quality Audit, Quality Review, Reports
Batch Formula Record & Master Formula Record
Handling of Complaints and Evaluation
Batch Formula Record & Master Formula Record
Quality Documentation & Distribution Records
UNIT 5:
Introduction: Calibration, Qualification, Validation
