Advanced Certificate in PharmaTech Compliance Procedures
-- ViewingNowThe Advanced Certificate in PharmaTech Compliance Procedures is a comprehensive course designed to meet the growing industry demand for professionals with expertise in pharmaceutical technology compliance. This certification equips learners with critical skills necessary to navigate the complex regulatory landscape, ensuring adherence to industry standards and best practices.
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⢠Regulatory Framework: Understanding FDA, EMA, and other global pharmaceutical regulations
⢠Quality Management Systems: Implementing and maintaining ISO 13485 and ISO 9001 standards
⢠Good Manufacturing Practices (GMP): Adhering to cGMP regulations for pharmaceutical manufacturing
⢠Pharmacovigilance: Monitoring, identifying, and preventing adverse effects of pharmaceutical products
⢠Clinical Trials: Managing clinical trial processes, documentation, and compliance
⢠Change Control: Managing changes in the pharmaceutical production process and facilities
⢠Document Management: Creating, maintaining, and controlling essential documentation for compliance
⢠Internal Audits: Performing internal audits to ensure compliance with regulations
⢠Corrective and Preventive Actions (CAPA): Implementing CAPA processes to address and prevent non-compliance
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