Professional Certificate in Biopharma Compliance & IP
-- ViewingNowProfessional Certificate in Biopharma Compliance & IP: A Critical Skills Course for Career Advancement in the Biopharma Industry. In today's rapidly evolving biopharma landscape, professionals with a deep understanding of compliance and intellectual property (IP) are in high demand.
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โข Introduction to Biopharma Compliance & IP: Regulatory framework, Intellectual Property protection, and their impact on the biopharma industry.
โข Regulatory Compliance in Biopharma: FDA regulations, GxP (Good Practice) guidelines, Quality Management Systems (QMS), and cGMP (current Good Manufacturing Practices).
โข Intellectual Property Rights in Biopharma: Patents, trademarks, copyrights, and trade secrets in the biopharma sector.
โข Patent Strategy & Management: Patent prosecution, patent enforcement, patent portfolio management, and freedom-to-operate assessments.
โข Biopharma IP Licensing & Technology Transfer: Licensing agreements, material transfer agreements, collaboration agreements, and research & development (R&D) agreements.
โข Biopharma Compliance Best Practices: Risk management, auditing, inspection readiness, and enforcement actions.
โข Data Integrity in Biopharma Compliance: Data integrity principles, ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) standards, and data governance.
โข Biopharma Compliance Ethics & Culture: Compliance programs, corporate culture, and whistleblower policies.
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