ADVANCED CERTIFICATION COURSE IN PHARMACEUTICAL MANUFACTURING

Course Summary: Advanced Certification in Pharmaceutical Manufacturing This course offers a detailed exploration into the complex world of pharmaceutical manufacturing, tailored for both newcomers and experienced professionals in the pharma industry. It encompasses a wide array of critical topics essential for ensuring the highest standards of product quality and safety. Key Aspects of the Course: Good Manufacturing Practices (GMP): In-depth understanding of GMP guidelines (Schedule M, WHO, USFDA). Emphasis on the importance of GMP compliance for product quality and safety. Facility Design and Building: Principles of designing pharmaceutical facilities. Impact of facility layout on product quality and safety. Clean Room Practices: Standards and protocols for clean room maintenance. Focus on contamination control and environmental monitoring. Quality Management Systems (QMS): Comprehensive overview of QMS in pharmaceutical manufacturing. Role of QMS in ensuring consistent product quality. Equipment Qualification and Calibration: Significance of equipment qualification and regular calibration. Ensuring accuracy and reliability in manufacturing processes. Sanitization and Hygiene: Methods and importance of proper sanitization. Role of hygiene in preventing product contamination. Training for Personnel: Training requirements and importance for pharmaceutical staff. Focus on continuous learning and GMP compliance. Audits and Inspections: Insight into the process and preparation for audits and regulatory inspections. Manufacturing Processes: Detailed look at manufacturing tablets, capsules, oral liquids, and injectables. Understanding specific challenges and quality considerations. Vendor Qualification: Criteria for selecting and qualifying vendors. Importance of vendor quality in the pharmaceutical supply chain.