Masterclass Certificate in Biopharma Quality by Design
-- ViewingNowThe Masterclass Certificate in Biopharma Quality by Design course is a comprehensive program that emphasizes the importance of quality-focused design in the biopharma industry. This course addresses the rising industry demand for professionals who can develop and implement quality by design (QbD) strategies, thereby enhancing product quality and reducing manufacturing costs.
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Here are the essential units for a Masterclass Certificate in Biopharma Quality by Design:
• Introduction to Biopharma Quality by Design: This unit will cover the basics of Quality by Design (QbD), including its history, benefits, and principles, with a specific focus on its application in the biopharma industry.
• Quality Target Product Profile (QTPP): This unit will explain how to develop a Quality Target Product Profile (QTPP), a critical tool in the QbD process that outlines the desired product quality characteristics.
• Critical Quality Attributes (CQAs): This unit will discuss how to identify and define Critical Quality Attributes (CQAs), the physical, chemical, or biological properties that must be controlled to ensure product quality.
• Design of Experiments (DoE): This unit will cover Design of Experiments (DoE), a statistical technique used to optimize the manufacturing process and ensure consistent product quality.
• Risk Assessment: This unit will explain how to conduct a risk assessment to identify and prioritize potential risks to product quality and patient safety.
• Process Control Strategies: This unit will discuss various process control strategies, including continuous process verification, to ensure consistent product quality and reduce risks.
• Quality Management Systems: This unit will cover Quality Management Systems (QMS) and their role in ensuring compliance with regulatory requirements and maintaining product quality.
• Regulatory Considerations: This unit will examine the regulatory requirements for QbD in the biopharma industry, including guidance from the FDA and ICH.
• Case Studies: This unit will present real-world case studies that illustrate the successful implementation of QbD in biopharma manufacturing.
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