Executive Development Programme in Pharmaceutical Auditing: Actionable Knowledge
-- ViewingNowThe Executive Development Programme in Pharmaceutical Auditing: Actionable Knowledge certificate course is a comprehensive program designed to provide learners with the essential skills needed to excel in pharmaceutical auditing. This course is crucial in an industry where regulatory compliance is paramount, and audits are a regular occurrence.
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โข Introduction to Pharmaceutical Auditing: Understanding the auditing process, types of audits (GxP, financial, operational), and the role of an auditor in the pharmaceutical industry.
โข Regulatory Compliance: Overview of regulations and guidelines (FDA, EMA, ICH) that impact pharmaceutical auditing. Analyzing the importance of adhering to these regulations and the consequences of non-compliance.
โข Risk Management in Pharmaceutical Auditing: Identifying, assessing, and prioritizing risks associated with pharmaceutical operations and how to implement controls to mitigate those risks.
โข Quality Management Systems (QMS): Examining the components of a QMS, including quality assurance, quality control, and change management. Understanding the role of a QMS in ensuring regulatory compliance.
โข Audit Planning and Preparation: Techniques for planning and preparing for audits, including defining the audit scope, creating an audit plan, and selecting the audit team.
โข Conducting Audits: Best practices for conducting audits, including document review, interview techniques, and observation methods. Understanding how to gather and document evidence to support audit findings.
โข Audit Reporting: Techniques for writing clear, concise, and actionable audit reports. Understanding how to present findings to stakeholders and develop corrective action plans.
โข Follow-up and Monitoring: Procedures for following up on corrective actions and monitoring progress. Understanding how to evaluate the effectiveness of corrective actions and identify areas for improvement.
โข Professional Development: Strategies for continuous learning and professional development in pharmaceutical auditing, including staying up-to-date with regulatory changes and industry trends.
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