This course provides participants with a comprehensive understanding of the principles, processes, and documentation requirements involved in New Product Development (NPD) studies and reports within regulated industries, particularly pharmaceutical, biotechnology, medical device, food, cosmetics, and healthcare sectors. It focuses on the scientific, technical, regulatory, and quality aspects required to successfully develop a new product from concept through commercialization.
Created by Dr. YASSER MEKKY
EN/AR [Auto]
Join Now| # | Content |
|---|---|
| 1 | Module 1: Introduction to New Product Development |
| 2 | Module 2: Product Development Planning |
| 3 | Module 3: Regulatory and Quality Requirements |
| 4 | Module 4: Formulation Development Studies |
| 5 | Module 5: Process Development Studies |
| 6 | Module 6: Analytical Development Studies |
| 7 | Module 7: Stability Studies |
| 8 | Module 8: Quality Risk Management in Product Development |
| 9 | Module 9: Technology Transfer and Scale-Up |
| 10 | Module 10: Development Reports and Documentation |
| 11 | Module 11: Regulatory Submission Documentation |
| 12 | Module 12: Product Lifecycle Management |
| 13 | Module 13: Practical Workshops and Case Studies |
| # | Outcomes |
|---|---|
| • Explain the stages of the new product development lifecycle. | |
| • Prepare development plans and study protocols. | |
| • Identify critical product and process development requirements. | |
| • Design and document formulation and process development studies. | |
| • Interpret analytical development and stability study results. | |
| • Prepare comprehensive product development reports. | |
| • Apply risk management principles during development activities. | |
| • Understand technology transfer requirements from development to manufacturing. | |
| • Support preparation of regulatory submission documents. | |
| • Ensure development documentation meets GMP and regulatory expectations. |
| # | Participants |
|---|---|
| 1 |
�
• Research and Development (R&D) Scientists
|
| 2 |
�
• Formulation Development Scientists
|
| 3 |
�
• Analytical Development Scientists
|
| 4 |
�
• Process Development Engineers
|
| 5 |
�
• Manufacturing Engineers
|
| 6 |
�
• Quality Assurance (QA) personnel
|
| 7 |
�
• Quality Control (QC) personnel
|
| 8 |
�
• Regulatory Affairs professionals
|
| 9 |
�
• Validation Specialists
|
| 10 |
�
• Technology Transfer Teams
|
| 11 |
�
• Project Managers
|
| 12 |
�
• Product Lifecycle Management Teams
|
| 13 |
�
• Pharmaceutical, Biotechnology, Medical Device, Food, Cosmetics, and Healthcare professionals
|
| 14 |
�
• Anyone involved in product development, documentation, or commercialization activities
|