Certificate in Biotech Regulatory Compliance Masterclass
-- ViewingNowThe Certificate in Biotech Regulatory Compliance Masterclass is a comprehensive course designed to empower learners with the essential skills needed to excel in the biotechnology industry. This program focuses on the critical aspects of regulatory compliance, an area of increasing importance in biotechnology.
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⢠Introduction to Biotech Regulatory Compliance: Overview of the regulatory landscape, compliance requirements, and the importance of adhering to regulations in biotechnology.
⢠Regulatory Agencies and Guidelines: Detailed exploration of key agencies (e.g., FDA, EMA) and guidelines shaping the biotech industry, such as GLP, GCP, and GMP.
⢠Quality Management Systems (QMS): Understanding the implementation and maintenance of QMS, including ISO 9001 and ISO 13485, and their role in regulatory compliance.
⢠Clinical Trials and Data Management: Best practices for managing clinical trial data, ensuring subject privacy, and adhering to ICH-GCP guidelines.
⢠Biotech Product Lifecycle Management: Strategies for managing the entire lifecycle of biotech products, from research and development to market withdrawal.
⢠Pharmacovigilance and Adverse Event Reporting: Monitoring, assessing, and reporting adverse events and pharmacovigilance activities in compliance with regulatory requirements.
⢠Regulatory Submissions and Approvals: Processes and strategies for preparing and submitting applications to regulatory agencies, including eCTD submissions.
⢠Regulatory Inspections and Audits: Preparing for and managing regulatory inspections and audits, ensuring continuous compliance.
⢠Risk Management in Biotech Regulatory Compliance: Implementing risk management strategies in compliance with ISO 14971, FMEA, and HACCP guidelines.
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