Professional Certificate in QA in Therapeutics Manufacturing
-- ViewingNowThe Professional Certificate in QA in Therapeutics Manufacturing is a comprehensive course designed to meet the growing industry demand for qualified quality assurance (QA) professionals in therapeutics manufacturing. This program equips learners with essential skills needed to succeed in QA roles, including regulatory compliance, documentation, change control, and deviation management.
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โข Quality Assurance Fundamentals: Introduction to QA principles, regulatory requirements, and industry standards in therapeutics manufacturing.
โข Good Manufacturing Practices (GMPs): Comprehensive overview of GMPs, with a focus on cGMP regulations, quality systems, and critical control points.
โข Quality Risk Management: Risk identification, assessment, and control in therapeutics manufacturing, including Ishikawa diagrams and FMEA.
โข Validation and Qualification: Understanding the principles of validation and qualification, including process validation, equipment qualification, and cleaning validation.
โข Change Management: Implementing change management processes, including change control, impact assessment, and implementation.
โข Documentation and Record Keeping: Best practices for document management, record keeping, and data integrity in therapeutics manufacturing.
โข Quality Control and Laboratory Testing: Quality control principles, laboratory testing methodologies, and analytical techniques in therapeutics manufacturing.
โข Auditing and Inspection Preparation: Conducting internal audits, preparing for regulatory inspections, and managing inspection findings.
โข Continuous Improvement: Implementing continuous improvement strategies, including Six Sigma, Lean, and Kaizen, in therapeutics manufacturing.
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