Program Overview
This course provides in-depth knowledge of pharmaceutical packaging design, from regulatory compliance and material selection to cutting-edge innovations like smart packaging and sustainability practices. The course blends conceptual understanding, situational awareness, and real-world problem-solving to address the most pressing challenges faced by professionals in the pharma packaging domain. Participants will gain hands-on insights into optimizing packaging design for better product integrity, regulatory adherence, and cost-efficiency.
Features
- Understand the key principles and regulatory requirements in pharma packaging design.
- Analyze real-life case studies to identify and solve packaging challenges.
- Evaluate material options and make informed decisions on cost-effective and compliant packaging.
- Design a packaging strategy that aligns with industry trends, sustainability, and patient needs.
Target audiences
- Pharmaceutical R&D, manufacturing, quality assurance, and packaging professionals
Curriculum
- 8 Sections
- 41 Lessons
- 2 Days
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- Introduction to Pharma Packaging6
- 1.1Definition and Purpose: Role of packaging in the pharmaceutical supply chain
- 1.2Types of Packaging: Primary, Secondary, and Tertiary packaging
- 1.3Materials: Glass, plastics, metals, blister packs, strip packs, cartons
- 1.4Keywords: Barrier properties, Tamper-evident seals, Sterility, Child-resistant packaging
- 1.5Case study: Effective packaging solutions in pharma
- 1.6Interactive Activity: Group brainstorming on identifying packaging needs for specific pharma products
- Regulatory and Compliance Requirements6
- 2.1Key Regulations: USFDA, EMA, ICH, ISO 11607, and their requirements
- 2.2Good Manufacturing Practices (GMP): Packaging compliance
- 2.3Labeling Guidelines: Serialization, barcoding, and patient safety
- 2.4Keywords: Track and Trace, Serialization, Counterfeit prevention, Stability studies
- 2.5Case Study: Non-compliance and its impact on market recall
- 2.6Interactive Activity: Compliance audit simulation for an existing packaging design
- Packaging Design Process6
- 3.1Design Thinking in Packaging: From concept to final product
- 3.2Considerations: Product stability, moisture resistance, light sensitivity, and usability
- 3.3Prototyping and Testing: Ensuring quality and robustness in design
- 3.4Keywords: Design for Patient Experience (DFPE), Human Factors Engineering
- 3.5Case Study: Design of packaging for heat-sensitive vaccines
- 3.6Interactive Activity: Sketch packaging designs for a hypothetical product
- Innovations in Pharma Packaging5
- 4.1Smart Packaging: RFID tags, IoT-enabled tracking, QR codes for patient education
- 4.2Sustainable Packaging: Eco-friendly materials, recyclability, and cost optimization
- 4.3Keywords: Active packaging, Intelligent packaging, Biodegradable polymers
- 4.4Smart packaging case studies improving patient compliance
- 4.5Group discussion on integrating smart and sustainable elements into existing designs
- Material Selection and Cost Optimization5
- 5.1Material Science: Choosing the right packaging material for solid, liquid, and injectable drugs
- 5.2Cost Factors: Balancing quality, compliance, and budget
- 5.3Keywords: Thermoforming, Cold-forming, Single-use plastics, HDPE, PET, PVC
- 5.4Case Study: Cost-effective packaging material alternatives
- 5.5Interactive Activity: Material selection exercise for cost-effective and compliant solutions
- Packaging Testing and Validation5
- 6.1Key Tests: Stability testing, leak detection, transportation simulation
- 6.2Validation Protocols: Process validation and performance verification
- 6.3Keywords: Accelerated stability testing, Shock tests, Drop tests
- 6.4Case Study: Packaging failure during transit and preventive solutions
- 6.5Interactive Simulation: Perform mock validation exercises for a sample packaging
- Resolving Real-Life Challenges in Pharma Packaging4
- 7.1Key Challenges: Counterfeiting, product integrity, regulatory barriers, and sustainability pressure
- 7.2Industry Trends: Circular economy, digitization, and automation in packaging
- 7.3Addressing counterfeiting through serialization in a major pharma company
- 7.4Breakout groups solve real-life scenarios related to: Addressing packaging for a fragile drug; Designing a cost-optimized and compliant solution
- Packaging Design Strategy and Roadmap4
- 8.1Future Trends: AI-driven packaging design, sustainability targets, and smart packaging adoption
- 8.2Action Plan: Defining packaging strategies for pharma products
- 8.3Keywords: AI optimization, Circular packaging systems, Supply chain integration
- 8.4Interactive Activity: Create a 6-month packaging improvement roadmap for their organizations
Instructor
