Certificate in Biopharma Compliance Legal Framework
-- ViewingNowThe Certificate in Biopharma Compliance Legal Framework course is a vital program for professionals seeking to excel in the biopharmaceutical industry. This course is designed to empower learners with an in-depth understanding of the complex legal landscape that governs biopharma compliance.
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⢠Introduction to Biopharma Compliance Legal Framework: Understanding the legal landscape of the biopharma industry, including regulations, laws, and guidelines.
⢠FDA Regulations and Guidelines: Comprehensive overview of FDA regulations, including 21 CFR Part 11, cGMP, and GTP, and their impact on biopharma compliance.
⢠EU GMP Guidelines: Deep dive into EU GMP guidelines, their significance, and how they differ from FDA regulations.
⢠Quality Management Systems (QMS): Understanding QMS, its components, and how it relates to biopharma compliance.
⢠Risk Management in Biopharma: Overview of risk management principles, including ICH Q9, and their application in the biopharma industry.
⢠Data Integrity in Biopharma: Understanding the importance of data integrity, ALCOA+ principles, and best practices for maintaining data integrity.
⢠Audits and Inspections: Comprehensive overview of audits and inspections, including FDA inspections, and how to prepare for them.
⢠Enforcement and Penalties: Understanding the consequences of non-compliance, including warning letters and consent decrees, and how to avoid them.
⢠Biopharma Compliance Trends: Staying up-to-date with the latest biopharma compliance trends, including the impact of emerging technologies on compliance.
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