Professional Certificate in Biotech Quality Assurance: Standards Adherence
-- ViewingNowThe Professional Certificate in Biotech Quality Assurance: Standards Adherence is a comprehensive course designed to equip learners with the essential skills necessary for success in the biotechnology industry. This program emphasizes the importance of adhering to industry standards, ensuring the production of safe and effective biotech products.
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⢠Regulatory Frameworks in Biotech Quality Assurance: An overview of the regulatory bodies and frameworks that govern biotech quality assurance, including FDA, EMA, and ICH guidelines.
⢠Good Laboratory Practices (GLP): Understanding the principles and implementation of GLP in biotech QA, including record keeping, data integrity, and inspection readiness.
⢠Good Manufacturing Practices (GMP): The fundamental principles and implementation of GMP in biotech QA, including quality control, documentation, and deviations management.
⢠Quality Risk Management in Biotech: Introduction to quality risk management principles, tools, and techniques, including FMEA, HACCP, and risk assessment.
⢠Quality Management Systems in Biotech: Overview of quality management systems and their implementation in biotech QA, including ISO 13485 and ISO 9001.
⢠Validation and Qualification in Biotech: Understanding the principles and practices of validation and qualification, including IQ, OQ, and PQ, and computer system validation.
⢠Change Management in Biotech QA: Introduction to change management principles and practices, including impact assessment, risk management, and implementation.
⢠Auditing and Inspection Preparation in Biotech QA: Understanding the principles and practices of internal and external audits, including preparation for regulatory inspections.
⢠Data Integrity in Biotech QA: Overview of data integrity principles, practices, and regulations, including ALCOA+ and data governance.
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- Quality Assurance Manager: These professionals oversee the implementation and monitoring of quality assurance systems and processes within biotech firms. They ensure compliance with regulations, guidelines, and best practices.
- QA Specialist: QA Specialists work closely with various departments to develop, maintain, and improve quality assurance policies and procedures, addressing specific aspects of biotech manufacturing and research.
- QA Auditor: QA Auditors perform internal and external audits to assess the effectiveness and efficiency of quality assurance systems, processes, and controls. Their goal is to identify areas of improvement and potential non-compliance issues.
- QA Technician: QA Technicians are responsible for conducting tests, inspections, and measurements to ensure product quality during biotech production processes. They also assist in maintaining documentation and records related to quality control.
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