Global Certificate in Pharma Compliance Techniques
-- ViewingNowThe Global Certificate in Pharma Compliance Techniques is a comprehensive course designed to meet the growing industry demand for professionals with a deep understanding of pharmaceutical regulatory compliance. This course emphasizes the importance of adhering to global standards and regulations, ensuring the safety and efficacy of pharmaceutical products.
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• Global Pharma Compliance Overview: Understanding the global regulatory landscape, compliance frameworks and guidelines, and the role of a Compliance Technician in the pharmaceutical industry. • Quality Management Systems (QMS): Exploring the concept and implementation of QMS in pharmaceutical companies, including ISO 9001, ISO 13485, and cGMP regulations. • Good Distribution Practices (GDP): Examining GDP principles, guidelines, and requirements, with a focus on the storage, transportation, and distribution of pharmaceutical products. • Pharmacovigilance: Understanding the essentials of drug safety, adverse event reporting, and pharmacovigilance systems, in compliance with international regulations. • Data Integrity: Learning about data integrity principles, data lifecycle management, and ALCOA+ guidelines, ensuring the reliability and compliance of data in pharmaceutical operations. • Regulatory Affairs: Delving into the role of regulatory affairs in pharmaceutical compliance, including submission strategies, regulatory intelligence, and product lifecycle management. • Clinical Trials Compliance: Investigating the regulatory landscape, ICH-GCP guidelines, and best practices for clinical trial design, execution, and reporting to ensure compliance. • Anti-Counterfeiting and Diversion Control: Examining the challenges and solutions in combating counterfeit drugs, implementing diversion control strategies, and ensuring supply chain security. • Inspection Readiness and Response: Preparing for regulatory inspections, understanding the inspection process, and developing response strategies for potential findings and 483 observations.
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- BasicUnderstandingSubject
- ProficiencyEnglish
- ComputerInternetAccess
- BasicComputerSkills
- DedicationCompleteCourse
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- ThreeFourHoursPerWeek
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- TwoThreeHoursPerWeek
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