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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⢠Introduction to Biotech Compliance & Validation: Understanding regulatory requirements, industry standards, and best practices
⢠Regulatory Frameworks: An overview of FDA, EMA, and other global regulations
⢠Good Laboratory Practices (GLP): Implementing and maintaining GLP for biotech compliance
⢠Good Manufacturing Practices (GMP): Establishing and adhering to GMP guidelines in biotech manufacturing
⢠Risk Management in Biotech Compliance: Identifying, assessing, and mitigating risks in biotech operations
⢠Data Integrity & Documentation: Ensuring data accuracy, traceability, and security
⢠Quality Assurance & Quality Control: Implementing QA/QC systems for biotech products
⢠Validation & Qualification: Techniques for process, equipment, and cleaning validation
⢠Change Management in Biotech Compliance: Managing and documenting changes in biotech processes and systems
⢠Auditing & Inspection Preparation: Effective internal auditing strategies and preparing for regulatory inspections
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