Professional Certificate in Biotech for Regulatory Excellence
-- ViewingNowThe Professional Certificate in Biotech for Regulatory Excellence is a comprehensive course designed to meet the growing industry demand for professionals with a deep understanding of biotech regulations. This certificate equips learners with essential skills necessary to navigate the complex regulatory landscape of the biotech industry, providing a competitive edge in career advancement.
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GBP £ 140
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โข Introduction to Biotechnology: History, principles, and applications
โข Regulatory Landscape for Biotech Products: Overview of global regulations
โข Quality Systems and Good Manufacturing Practices: Key aspects for biotech companies
โข Biotech Product Development: Phases, strategies, and case studies
โข Clinical Trials and Data Management: ICH-GCP guidelines, safety, and efficacy
โข Regulatory Submissions and Documentation: Common submission types and formats
โข Regulatory Inspections and Audits: Preparation, execution, and follow-up
โข Pharmacovigilance and Risk Management: Adverse event reporting and risk minimization
โข Labeling and Packaging: Compliance, content, and design considerations
โข Post-Marketing Surveillance and Lifecycle Management: Monitoring, updates, and improvements
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