Global Certificate in Biotech Compliance & Regulations
-- ViewingNowThe Global Certificate in Biotech Compliance & Regulations is a crucial course that provides learners with comprehensive knowledge of regulatory frameworks in the biotechnology industry. This program highlights the importance of compliance, ensuring that biotech products meet the strict regulations required to protect public health and the environment.
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⢠Global Regulatory Landscape: An overview of global biotech regulations and compliance requirements, including key agencies and their roles (FDA, EMA, etc.)
⢠Good Laboratory Practices (GLP): Understanding GLP principles, compliance requirements, and their role in biotech research and development
⢠Good Manufacturing Practices (GMP): Learning GMP fundamentals, their impact on biotech manufacturing, and related global regulations
⢠Good Clinical Practices (GCP): Familiarizing with GCP principles, clinical trial regulations, and their importance in biotech research
⢠Quality Assurance and Quality Control (QA/QC): Exploring QA/QC systems, their significance in biotech compliance, and international quality standards
⢠Pharmacovigilance and Adverse Event Reporting: Understanding pharmacovigilance requirements, adverse event monitoring, and reporting processes
⢠Data Management and Integrity: Learning data management best practices, data integrity principles, and their role in biotech compliance
⢠Regulatory Affairs and Submissions: Mastering the regulatory submission process, document preparation, and engaging with regulatory agencies
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