Advanced Certificate in PharmaTech Quality Assurance Practices
-- ViewingNowThe Advanced Certificate in PharmaTech Quality Assurance Practices is a comprehensive course designed to empower learners with critical skills in the pharmaceutical industry. This program emphasizes the importance of quality assurance, an area that is increasingly vital as the industry strives to ensure safety, efficacy, and regulatory compliance.
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⢠Quality Management Systems (QMS): Overview, ISO 9001:2015 standards, and implementation in PharmaTech
⢠Good Manufacturing Practices (GMP): Regulations, compliance, and role in PharmaTech QA
⢠Quality Risk Management (QRM): Identification, assessment, and mitigation strategies
⢠Pharmaceutical Validation: Principles, types (process, equipment, and cleaning), and documentation requirements
⢠Change Control: Change request, evaluation, approval, and implementation processes
⢠Quality Assurance Audits: Internal, external, and supplier audits, and audit reporting
⢠Complaint Handling and CAPA (Corrective Action and Preventive Action): Procedures, documentation, and root cause analysis
⢠Pharmacovigilance: Adverse event reporting, drug safety monitoring, and regulatory requirements
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