2-Day Workshop on Pharmaceutical Engineering (PHARMAENG) by Tonex
This 2-day workshop on Pharmaceutical Engineering, organized by the International Society for Pharmaceutical Engineering (PHARMAENG), is designed to provide participants with a comprehensive understanding of technical and regulatory advancements throughout the entire pharmaceutical lifecycle. The workshop connects pharmaceutical knowledge to deliver manufacturing and supply chain innovation, operational excellence, and regulatory insights. This workshop aims to enhance industry efforts to develop, manufacture, and reliably deliver quality medicines to patients.
Learning Objectives
By the end of the workshop, participants will be able to:
- Understand Technical and Regulatory Advancements: Gain insights into the latest technical and regulatory advancements in the pharmaceutical industry.
- Enhance Manufacturing and Supply Chain Innovation: Learn strategies to drive innovation in manufacturing and supply chain processes.
- Achieve Operational Excellence: Develop skills to achieve operational excellence in pharmaceutical manufacturing and distribution.
- Implement Regulatory Insights: Understand and apply regulatory insights to ensure compliance and quality in pharmaceutical processes.
Audience
This workshop is ideal for:
- Pharmaceutical engineers
- Quality assurance and regulatory compliance professionals
- Production and manufacturing managers
- Supply chain and logistics professionals
- Research and development scientists
- Anyone involved in the pharmaceutical lifecycle
Workshop Modules
Day 1: Technical Advancements and Manufacturing Innovation
Module 1: Facilities & Equipment
- Overview of the latest advancements in pharmaceutical facilities and equipment
- Best practices for designing and maintaining state-of-the-art manufacturing facilities
- Ensuring compliance with regulatory standards for equipment and facilities
Hands-on Practical Workshop
- Interactive session on designing a compliant and efficient manufacturing facility
- Group activities to analyze and discuss equipment maintenance and optimization
Module 2: Information Systems
- Role of information systems in pharmaceutical manufacturing and supply chain management
- Latest trends in digital transformation and data analytics
- Implementing information systems to enhance operational efficiency and regulatory compliance
Hands-on Practical Workshop
- Participants develop strategies for integrating information systems into manufacturing processes
- Group discussions on data management and digital transformation
Module 3: Management
- Effective management practices in pharmaceutical engineering
- Leadership skills for driving innovation and operational excellence
- Techniques for managing cross-functional teams and projects
Hands-on Practical Workshop
- Role-playing exercises to practice leadership and management skills
- Group activities to develop management strategies for pharmaceutical projects
Day 2: Regulatory Insights and Quality Assurance
Module 4: Product Development
- Advances in pharmaceutical product development
- Regulatory considerations in product development
- Strategies for accelerating product development while ensuring quality and compliance
Hands-on Practical Workshop
- Participants work on case studies to develop and bring a pharmaceutical product to market
- Group discussions on balancing speed and compliance in product development
Module 5: Quality
- Importance of quality assurance in pharmaceutical manufacturing
- Techniques for implementing robust quality management systems
- Ensuring continuous improvement in quality processes
Hands-on Practical Workshop
- Interactive session on developing and implementing a quality management system
- Group activities to identify and address quality issues in manufacturing
Module 6: Regulatory
- Overview of key regulatory frameworks and standards (e.g., FDA, EMA, ICH)
- Navigating regulatory challenges in the pharmaceutical industry
- Strategies for achieving and maintaining regulatory compliance
Hands-on Practical Workshop
- Participants develop regulatory compliance plans for hypothetical scenarios
- Group discussions on best practices for navigating regulatory challenges
Module 7: Supply Chain
- Innovations in pharmaceutical supply chain management
- Strategies for ensuring a reliable and efficient supply chain
- Addressing supply chain challenges in the pharmaceutical industry
Hands-on Practical Workshop
- Interactive session on optimizing the pharmaceutical supply chain
- Group activities to develop solutions for common supply chain issues
Interactive Q&A and Discussion Sessions
- Open floor discussions with industry experts
- Addressing specific participant questions and scenarios
- Collaborative problem-solving and idea exchange