Certificate in PharmaTech Legal Requirements
-- ViewingNowThe Certificate in PharmaTech Legal Requirements course is a crucial program for professionals seeking to excel in the pharmaceutical industry. This course focuses on the legal frameworks and regulations that govern pharmaceutical technology, ensuring that learners are well-equipped to navigate the complex regulatory landscape of this field.
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โข Pharmaceutical Law and Ethics: Understanding the legal and ethical framework governing the pharmaceutical industry, including regulations, guidelines, and industry codes of practice.
โข Good Manufacturing Practices (GMP): Compliance with GMP regulations, including documentation, quality control, and record-keeping requirements.
โข Drug Approval Process: Overview of the drug approval process, including clinical trials, marketing authorization, and post-marketing surveillance.
โข Pharmacovigilance: Monitoring and reporting adverse drug reactions, ensuring patient safety, and maintaining compliance with pharmacovigilance regulations.
โข Labeling and Packaging Requirements: Compliance with regulations governing drug labeling, packaging, and distribution, including child-resistant packaging.
โข Prescription Drug Marketing Act (PDMA): Understanding the PDMA, its requirements, and implications for pharmaceutical marketing and distribution.
โข False Claims Act and Anti-Kickback Statute: Overview of the False Claims Act and Anti-Kickback Statute, their impact on the pharmaceutical industry, and compliance strategies.
โข Export and Import Regulations: Compliance with export and import regulations, including documentation, licensing, and customs requirements.
โข Data Privacy and Security: Protecting patient data, maintaining data privacy, and ensuring compliance with data security regulations.
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