Global Certificate in Biotech Manufacturing Due Diligence
-- ViewingNowThe Global Certificate in Biotech Manufacturing Due Diligence course is a comprehensive program designed to equip learners with critical skills in biotech manufacturing due diligence. This course is crucial in today's industry, where there is an increasing demand for professionals who understand the complexities of biotech manufacturing and can conduct thorough due diligence to ensure compliance and reduce risks.
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⢠Regulatory Frameworks in Biotech Manufacturing: Understanding the global regulatory landscape, including FDA, EMA, and other international agencies, is crucial for ensuring compliance and best practices in biotech manufacturing due diligence. ⢠Quality Management Systems: This unit will cover the essentials of Quality Management Systems (QMS) in biotech manufacturing, emphasizing ISO 13485, ISO 9001, and other relevant standards. ⢠Risk Management in Biotech Manufacturing: Students will learn how to implement risk management strategies and tools, such as Failure Mode and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP), to minimize risks in biotech manufacturing. ⢠Supply Chain Management: This unit will cover supply chain management best practices, including vendor selection, supplier evaluation, and supply chain risk mitigation. ⢠Good Manufacturing Practices (GMPs): This unit will provide an overview of GMPs, including cGMPs and the regulatory requirements for ensuring compliance. ⢠Technical Transfer in Biotech Manufacturing: Students will learn the best practices for transferring technology and processes between different manufacturing sites and how to ensure consistency in product quality. ⢠Data Integrity and Analytics: This unit will cover the essentials of data integrity, including data management, data analysis, and data reporting, in biotech manufacturing. ⢠Validation and Qualification in Biotech Manufacturing: Students will learn about the different types of validation, such as process validation, equipment validation, and computer system validation, as well as the importance of qualification in ensuring product quality. ⢠Change Management in Biotech Manufacturing: This unit will cover best practices for managing changes in biotech manufacturing, including change control, change evaluation, and change implementation. ⢠Quality Assurance and Quality Control: The final unit will cover the difference between quality assurance and quality control, and the essentials of
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