Professional Certificate in Process Validation
-- ViewingNowThe Professional Certificate in Process Validation is a comprehensive course designed to meet the growing industry demand for experts skilled in process validation. This certificate program emphasizes the importance of designing, conducting, and interpreting process validation studies to ensure product quality and compliance with regulatory standards.
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โข Introduction to Process Validation: Understanding the key concepts, benefits, and regulatory requirements of process validation in pharmaceutical and medical device manufacturing. โข Process Design and Development: Designing and developing a process, including identifying critical process parameters and establishing appropriate control strategies. โข Process Qualification: Conducting process qualification studies, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). โข Continuous Process Verification: Implementing continuous process verification programs, including monitoring, data analysis, and corrective action plans. โข Change Management: Managing changes to the process, including risk assessment, validation planning, and implementation. โข Documentation and Record Keeping: Maintaining accurate and complete documentation and records, including standard operating procedures (SOPs), batch records, and deviations. โข Process Validation in a Global Context: Understanding the challenges and opportunities of process validation in a global regulatory environment, including harmonization efforts and international standards. โข Case Studies and Best Practices: Examining real-world examples and best practices for successful process validation programs in the pharmaceutical and medical device industries.
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