Certificate in Process Validation Essentials
-- ViewingNowThe Certificate in Process Validation Essentials is a comprehensive course that equips learners with the fundamental skills necessary to excel in process validation. This course emphasizes the importance of creating and implementing effective validation strategies, ensuring product quality, and meeting regulatory requirements in various industries.
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โข Introduction to Process Validation: Overview of process validation, regulatory requirements, and benefits.
โข Process Design and Development: Understanding the principles of quality by design and risk management in process development.
โข Validation Master Plan: Creating a comprehensive validation master plan, outlining the scope and approach for process validation activities.
โข Process Qualification: Detailed exploration of the execution and documentation of process performance qualification (PPQ) studies, including operational and performance qualification.
โข Data Integrity and Analytics: Ensuring data integrity in process validation, with a focus on statistical analysis and trending.
โข Change Management: Implementing robust change management strategies in the context of process validation, addressing change evaluation, implementation, and revalidation.
โข Continuous Process Verification: Emphasizing the importance of continuous process verification (CPV) and its role in ongoing process monitoring and control.
โข Documentation and Reporting: Guidelines for preparing and maintaining comprehensive, accurate, and accessible documentation and reports.
โข Regulatory Inspection Preparation: Best practices in preparing for and managing regulatory inspections related to process validation activities.
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