Executive Development Programme in Pharma Compliance Audits
-- ViewingNowThe Executive Development Programme in Pharma Compliance Audits is a certificate course designed to empower professionals with the necessary skills to navigate the complex regulatory landscape of the pharmaceutical industry. This programme emphasizes the importance of compliance audits in ensuring adherence to laws, regulations, and industry standards, thereby reducing reputational risk and financial losses.
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โข Introduction to Pharma Compliance Audits: Understanding the importance of compliance, regulatory framework, and types of audits
โข Regulatory Bodies and Guidelines: Overview of FDA, EMA, and other relevant agencies; key compliance regulations and guidelines
โข Quality Management Systems (QMS): Establishing and maintaining a robust QMS for pharma companies
โข Good Manufacturing Practices (GMP): Compliance requirements, principles, and regulations
โข Good Laboratory Practices (GLP): Compliance requirements, principles, and regulations
โข Good Clinical Practices (GCP): Compliance requirements, principles, and regulations
โข Data Integrity in Pharma Audits: Ensuring data accuracy, reliability, and confidentiality
โข Risk Management in Pharma Compliance Audits: Identifying, assessing, and mitigating risks
โข Conducting Pharma Compliance Audits: Planning, executing, and reporting on audits; internal vs. external audits
โข Corrective and Preventive Action (CAPA): Implementing effective CAPA processes to address compliance gaps
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