Certificate in Compliance Documentation for Pharma
-- ViewingNowThe Certificate in Compliance Documentation for Pharma is a comprehensive course that equips learners with the essential skills needed to excel in the pharmaceutical industry. This program emphasizes the importance of compliance documentation, an area of increasing significance due to stricter regulations and heightened focus on quality control.
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⢠Unit 1: Introduction to Compliance Documentation in Pharma – concepts, definitions, and importance.
⢠Unit 2: Regulatory Framework – primary regulations and guidelines (FDA, EMA, etc.).
⢠Unit 3: Quality Management Systems – principles, implementation, and continuous improvement.
⢠Unit 4: Standard Operating Procedures (SOPs) – development, review, approval, and training.
⢠Unit 5: Document Control – creation, revision, distribution, and archival.
⢠Unit 6: Change Management – change identification, validation, and documentation.
⢠Unit 7: Risk Management – risk identification, assessment, and mitigation.
⢠Unit 8: Audits and Inspections – internal and external audits, inspection preparation, and response.
⢠Unit 9: Compliance Training – training programs, tracking, and continuous improvement.
⢠Unit 10: Corrective and Preventive Actions (CAPA) – CAPA system, root cause analysis, and verification.
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