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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โข Regulatory Framework: Understanding FDA, EMA, and other global pharmaceutical regulations
โข Quality Management Systems: Implementing and maintaining ISO 13485 and ISO 9001 standards
โข Good Manufacturing Practices (GMP): Adhering to cGMP regulations for pharmaceutical manufacturing
โข Pharmacovigilance: Monitoring, identifying, and preventing adverse effects of pharmaceutical products
โข Clinical Trials: Managing clinical trial processes, documentation, and compliance
โข Change Control: Managing changes in the pharmaceutical production process and facilities
โข Document Management: Creating, maintaining, and controlling essential documentation for compliance
โข Internal Audits: Performing internal audits to ensure compliance with regulations
โข Corrective and Preventive Actions (CAPA): Implementing CAPA processes to address and prevent non-compliance
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