Professional Certificate in Compliance Monitoring for Pharma
-- ViewingNowThe Professional Certificate in Compliance Monitoring for Pharma is a comprehensive course designed to equip learners with critical skills in ensuring adherence to regulatory standards in the pharmaceutical industry. This program emphasizes the importance of compliance, an area of increasing demand due to stringent regulations and the need for transparency.
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⢠Introduction to Compliance Monitoring for Pharma: Understanding the regulatory landscape, compliance roles, and monitoring objectives.
⢠Pharma Regulations and Guidelines: An overview of FDA, EMA, and other relevant regulations and guidelines for pharmaceutical compliance monitoring.
⢠Quality Management Systems (QMS): Establishing and maintaining a QMS, including quality assurance, quality control, and documentation.
⢠Risk Management in Pharma Compliance: Identifying, assessing, and controlling risks in pharmaceutical compliance monitoring.
⢠Data Integrity and Systems Validation: Ensuring data integrity, implementing data governance, and validating systems.
⢠Auditing and Inspection Preparation: Conducting internal audits, preparing for external inspections, and managing audit findings.
⢠Pharmacovigilance and Adverse Event Reporting: Monitoring and reporting adverse events, pharmacovigilance systems, and signal detection.
⢠Supply Chain Management and Distribution Controls: Ensuring supply chain integrity, implementing distribution controls, and managing product recalls.
⢠Training and Competence Management: Developing training programs, assessing competence, and maintaining training records.
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