Advanced Process Engineering in Pharmaceutical Manufacturing for Engineers
Length: 2 days
The Advanced Process Engineering in Pharmaceutical Manufacturing training course by Tonex is designed to provide an in-depth understanding of the principles and practices essential to process engineering within the pharmaceutical industry.
This course focuses on advanced methodologies, cutting-edge technologies, and regulatory considerations to enhance the efficiency, quality, and safety of pharmaceutical manufacturing processes.
Participants will gain practical insights into optimizing production systems, implementing robust quality control measures, and complying with global regulatory standards.
Learning Objectives:
- Understand the fundamental and advanced principles of process engineering in pharmaceutical manufacturing.
- Apply advanced process control techniques to optimize pharmaceutical production.
- Implement quality by design (QbD) and process analytical technology (PAT) for improved product quality.
- Navigate regulatory frameworks and ensure compliance with FDA, EMA, and other global standards.
- Utilize data analytics and digital tools to enhance process efficiency and decision-making.
- Develop strategies for continuous improvement and innovation in pharmaceutical manufacturing processes.
Audience:
- Process Engineers
- Manufacturing Engineers
- Quality Assurance/Quality Control Professionals
- Regulatory Affairs Specialists
- Production Managers
- R&D Scientists
- Pharmaceutical Consultants
- Industrial Engineers
Course Modules:
- Introduction to Advanced Process Engineering
- Overview of pharmaceutical manufacturing processes
- Key principles of process engineering
- Process design and development
- Scale-up considerations
- Case studies in process engineering
- Future trends and innovations
- Process Control and Optimization
- Advanced process control techniques
- Process optimization methodologies
- Implementation of automation in manufacturing
- Statistical process control (SPC)
- Real-time monitoring and control
- Troubleshooting and problem-solving
- Quality by Design (QbD) and Process Analytical Technology (PAT)
- Fundamentals of QbD in pharmaceutical manufacturing
- Implementation of PAT tools and techniques
- Risk management and mitigation
- Design of experiments (DOE)
- Real-time quality monitoring
- Case studies on QbD and PAT
- Regulatory Compliance and Standards
- Overview of global regulatory frameworks (FDA, EMA, etc.)
- Good Manufacturing Practices (GMP)
- Validation and qualification processes
- Documentation and reporting requirements
- Regulatory submission strategies
- Compliance auditing and inspections
- Data Analytics and Digital Transformation
- Role of data analytics in process engineering
- Big data and its applications in manufacturing
- Digital twins and virtual simulation
- Predictive analytics and machine learning
- Integration of IoT in pharmaceutical processes
- Cybersecurity considerations in digital transformation
- Continuous Improvement and Innovation
- Lean manufacturing principles
- Six Sigma methodologies
- Continuous improvement frameworks
- Innovation management in pharmaceutical manufacturing
- Case studies on successful improvement initiatives
- Future outlook and emerging technologies