Professional Certificate in Biopharma Compliance Assurance Validation
-- ViewingNowThe Professional Certificate in Biopharma Compliance Assurance Validation is a comprehensive course designed to equip learners with the essential skills necessary for success in the biopharma industry. This program focuses on the importance of compliance assurance, an area of critical importance for biopharma organizations as they must adhere to strict regulations to ensure product quality and patient safety.
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⢠Unit 1: Introduction to Biopharma Compliance Assurance Validation
⢠Unit 2: Regulatory Framework for Biopharma Compliance
⢠Unit 3: Quality Management Systems in Biopharma
⢠Unit 4: Risk Management in Biopharma Compliance
⢠Unit 5: Validation Master Plans
⢠Unit 6: Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification (DQ, IQ, OQ, PQ)
⢠Unit 7: Change Management and Re-validation in Biopharma
⢠Unit 8: Data Integrity and Documentation Control
⢠Unit 9: Auditing and Inspection Readiness in Biopharma
⢠Unit 10: Continuous Improvement and Trend Analysis in Biopharma Compliance
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