Professional Certificate in Pharma Compliance Strategies
-- ViewingNowThe Professional Certificate in Pharma Compliance Strategies is a comprehensive course designed to empower learners with the essential skills for success in the pharmaceutical industry. This program focuses on the importance of compliance strategies, an area of increasing significance in the highly-regulated pharmaceutical sector.
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โข Understanding Pharma Regulations: An overview of the regulatory landscape for pharmaceutical companies, including FDA regulations, GxP (Good Practice) guidelines, and international standards.
โข Quality Risk Management: An introduction to quality risk management principles and their application in the pharmaceutical industry, including risk identification, assessment, and mitigation strategies.
โข Pharmacovigilance: An exploration of the pharmacovigilance process, including adverse event reporting, signal detection, and benefit-risk assessment.
โข Clinical Trial Compliance: A review of regulations and best practices for clinical trial design, conduct, and reporting, including ICH-GCP (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice) guidelines.
โข Promotional Compliance: An examination of regulations governing pharmaceutical marketing and promotional activities, including off-label promotion and sunshine laws.
โข Data Integrity in Pharma: A discussion of data integrity principles, including ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) and ALCOA-Plus, and their application in the pharmaceutical industry.
โข Supply Chain Compliance: An exploration of regulations and best practices for pharmaceutical supply chain management, including DSCSA (Drug Supply Chain Security Act) and GDP (Good Distribution Practice) guidelines.
โข Compliance Program Development: A review of the process for developing and implementing a compliance program, including training, monitoring, and auditing.
โข Compliance Roles and Responsibilities: An examination of the roles and responsibilities of compliance professionals in the pharmaceutical industry, including compliance officers, quality assurance, and legal counsel.
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