Quality Control in Biopharmaceutical Engineering
( 30 Modules )

Module #1
Introduction to Quality Control
Overview of quality control principles and importance in biopharmaceutical engineering

Module #2
Regulatory Framework
International regulations and guidelines for quality control in biopharmaceutical manufacturing

Module #3
Good Manufacturing Practices (GMP)
Principles and implementation of GMP in biopharmaceutical manufacturing

Module #4
Quality Control Strategy
Development and implementation of a quality control strategy in biopharmaceutical manufacturing

Module #5
Raw Materials Control
Quality control of raw materials in biopharmaceutical manufacturing

Module #6
In-Process Control
Quality control during biopharmaceutical manufacturing process

Module #7
Finished Product Control
Quality control of finished biopharmaceutical products

Module #8
Analytical Method Validation
Principles and procedures for analytical method validation

Module #9
Equipment Qualification and Calibration
Qualification and calibration of equipment used in biopharmaceutical manufacturing

Module #10
Validation of Manufacturing Processes
Principles and procedures for validation of biopharmaceutical manufacturing processes

Module #11
Sterilization and Sanitization
Principles and procedures for sterilization and sanitization in biopharmaceutical manufacturing

Module #12
Contamination Control
Principles and procedures for contamination control in biopharmaceutical manufacturing

Module #13
Packaging and Labeling Control
Quality control of packaging and labeling of biopharmaceutical products

Module #14
Storage and Distribution Control
Quality control of storage and distribution of biopharmaceutical products

Module #15
Documentation and Record Keeping
Principles and procedures for documentation and record keeping in biopharmaceutical manufacturing

Module #16
Audit and Inspection
Preparation for audits and inspections in biopharmaceutical manufacturing

Module #17
Corrective Action and Preventive Action (CAPA)
Principles and procedures for corrective action and preventive action in biopharmaceutical manufacturing

Module #18
Risk Management
Principles and procedures for risk management in biopharmaceutical manufacturing

Module #19
Quality Control in Biotechnology
Specific quality control considerations in biotechnology manufacturing

Module #20
Quality Control in Vaccine Manufacturing
Specific quality control considerations in vaccine manufacturing

Module #21
Quality Control in Cell and Gene Therapy
Specific quality control considerations in cell and gene therapy manufacturing

Module #22
Quality Control in Biologics Manufacturing
Specific quality control considerations in biologics manufacturing

Module #23
Quality Metrics and Trending
Use of quality metrics and trending to monitor and improve quality control

Module #24
Quality Control in Supply Chain Management
Quality control considerations in biopharmaceutical supply chain management

Module #25
Quality Control and Regulatory Affairs
Interaction between quality control and regulatory affairs in biopharmaceutical manufacturing

Module #26
Quality Control and Continuous Improvement
Role of quality control in continuous improvement in biopharmaceutical manufacturing

Module #27
Quality Control and Lean Manufacturing
Application of lean manufacturing principles to quality control in biopharmaceutical manufacturing

Module #28
Quality Control and Six Sigma
Application of six sigma principles to quality control in biopharmaceutical manufacturing

Module #29
Quality Control and Industry 4.0
Impact of industry 4.0 on quality control in biopharmaceutical manufacturing

Module #30
Course Wrap-Up & Conclusion
Planning next steps in Quality Control in Biopharmaceutical Engineering career

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Quality Control in Biopharmaceutical Engineering ( 30 Modules )

Quality Control in Biopharmaceutical Engineering
( 30 Modules )