Professional Certificate in Biotech Compliance & Validation
-- ViewingNowThe Professional Certificate in Biotech Compliance & Validation is a comprehensive course designed to meet the growing industry demand for experts skilled in compliance and validation processes. This certification equips learners with critical skills necessary to ensure adherence to regulations, standards, and guidelines in the biotechnology industry.
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โข Introduction to Biotech Compliance & Validation: Understanding regulatory requirements, industry standards, and best practices
โข Regulatory Frameworks: An overview of FDA, EMA, and other global regulations
โข Good Laboratory Practices (GLP): Implementing and maintaining GLP for biotech compliance
โข Good Manufacturing Practices (GMP): Establishing and adhering to GMP guidelines in biotech manufacturing
โข Risk Management in Biotech Compliance: Identifying, assessing, and mitigating risks in biotech operations
โข Data Integrity & Documentation: Ensuring data accuracy, traceability, and security
โข Quality Assurance & Quality Control: Implementing QA/QC systems for biotech products
โข Validation & Qualification: Techniques for process, equipment, and cleaning validation
โข Change Management in Biotech Compliance: Managing and documenting changes in biotech processes and systems
โข Auditing & Inspection Preparation: Effective internal auditing strategies and preparing for regulatory inspections
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