Global Certificate in Compliance Enforcement for Pharma
-- ViewingNowThe Global Certificate in Compliance Enforcement for Pharma is a comprehensive course that equips learners with critical skills needed to navigate the complex regulatory landscape of the pharmaceutical industry. This program emphasizes the importance of compliance enforcement, ensuring that participants are well-versed in industry best practices and regulatory requirements.
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⢠Introduction to Compliance Enforcement in Pharma: Understanding the regulatory landscape, compliance requirements, and the role of compliance enforcement in the pharmaceutical industry.
⢠Pharmaceutical Quality Systems: Establishing and maintaining a quality management system, including quality assurance, quality control, and document management.
⢠Regulatory Affairs and Compliance: Overview of global regulations, including GxP (Good Practice) guidelines, FDA regulations, EMA guidelines, and ICH (International Council for Harmonisation) standards.
⢠Good Manufacturing Practices (GMP): Comprehensive understanding of GMP principles, including production, laboratory controls, packaging and labeling, and distribution.
⢠Good Clinical Practices (GCP): Overview of GCP guidelines for clinical trials, including design, conduct, performance, monitoring, auditing, recording, analyses, and reporting.
⢠Good Laboratory Practices (GLP): Understanding the principles of GLP in preclinical research, including non-clinical testing and data management.
⢠Good Distribution Practices (GDP): Overview of GDP guidelines, including storage, transportation, and handling of pharmaceutical products.
⢠Pharmacovigilance and Risk Management: Implementing and maintaining pharmacovigilance systems for drug safety monitoring, risk assessment, and risk management.
⢠Data Integrity and Computer Systems Validation: Ensuring data integrity and compliance with electronic record-keeping and computer system validation requirements.
⢠Compliance Enforcement Strategies: Developing and implementing effective enforcement strategies, including audits, inspections, and investigations.
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