Postgraduate Certificate in Pharmaceutical Batch Release QA
-- ViewingNowThe Postgraduate Certificate in Pharmaceutical Batch Release QA is a comprehensive course that provides learners with the essential skills needed for career advancement in the pharmaceutical industry. This course focuses on the importance of batch release quality assurance, a critical process in pharmaceutical production ensuring medications meet required standards before distribution.
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โข Batch Release Fundamentals: Overview of the batch release process, regulatory requirements, and quality assurance principles
โข Pharmaceutical Quality Systems: Establishing and maintaining a quality management system in accordance with ICH Q10
โข Good Manufacturing Practices (GMPs): Compliance with cGMP regulations, risk management, and deviation handling
โข Documentation and Record Keeping: Essential documentation for pharmaceutical batch release, including batch records, SOPs, and deviation reports
โข Regulatory Compliance: Understanding global regulations, guidance documents, and inspection readiness
โข Analytical Method Validation: Validation techniques, analytical method development, and verification for batch release
โข Stability Testing and Data Analysis: ICH stability guidelines, stability study design, and statistical data analysis
โข Change Management and Control: Implementing change management systems and change control strategies
โข Quality Risk Management: Applying ICH Q9 principles in identifying, assessing, and mitigating risks
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