Global Certificate in Combination Product Quality Assurance Protocols
-- ViewingNowThe Global Certificate in Combination Product Quality Assurance Protocols is a comprehensive course designed to meet the growing industry demand for experts in the field. This certificate program emphasizes the importance of quality assurance in the development, production, and post-market surveillance of combination products, which are increasingly crucial in the pharmaceutical and medical device industries.
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⢠Combination Product Quality Assurance Fundamentals: Understanding the basics of combination products, quality assurance principles, and regulatory requirements.
⢠Design Control and Development Process: Implementing design control processes for combination products, including design inputs, outputs, and verification/validation activities.
⢠Risk Management for Combination Products: Applying ISO 14971 and other risk management methodologies to combination products, identifying and assessing risks, and implementing risk mitigation strategies.
⢠Raw Material and Component Management: Procuring, controlling, and managing raw materials and components for combination products, ensuring compliance with regulatory requirements.
⢠Production and Process Control: Establishing and maintaining production and process control systems for combination products, ensuring consistent and reliable product quality.
⢠Sterilization and Aseptic Processing: Understanding and implementing sterilization and aseptic processing techniques for combination products, ensuring product sterility and microbial control.
⢠Quality Systems and Documentation: Implementing quality systems and documentation processes for combination products, ensuring compliance with regulatory requirements and industry best practices.
⢠Supplier Quality Assurance: Managing and monitoring suppliers to ensure compliance with regulatory requirements and quality standards for combination products.
⢠Change Management and Continuous Improvement: Implementing change management and continuous improvement processes for combination products, ensuring ongoing product and process optimization.
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