Professional Certificate in Pharma QA and Regulatory Affairs
-- ViewingNowThe Professional Certificate in Pharma QA and Regulatory Affairs is a comprehensive course designed to provide learners with critical skills in quality assurance and regulatory affairs, essential in the pharmaceutical industry. This program emphasizes the importance of compliance, good manufacturing practices (GMP), and regulatory strategies to ensure pharmaceutical products' safety, efficacy, and quality.
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โข Introduction to Pharma QA and Regulatory Affairs: Roles, responsibilities, and key regulations
โข Quality Management Systems (QMS): ISO 9001, ICH Q10, and cGMPs
โข Regulatory Compliance: FDA, EMA, and MHRA regulations
โข Pharmaceutical Quality Assurance: Quality planning, assurance, and control
โข Regulatory Affairs Management: Product registration, variations, and renewals
โข Pharmacovigilance: Drug safety monitoring, reporting, and risk management
โข Clinical Trials Regulation: ICH GCP, GMP, and regulatory requirements
โข Labeling, Packaging, and Artwork Control: Regulations, guidelines, and best practices
โข Quality Risk Management: ICH Q9 and integrated risk management approach
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