Global Certificate in Drug Delivery Compliance Standards
-- ViewingNowThe Global Certificate in Drug Delivery Compliance Standards is a comprehensive course designed to meet the growing industry demand for experts who understand the intricacies of drug delivery regulations. This certificate program emphasizes the importance of compliance in drug delivery systems and equips learners with essential skills for career advancement.
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โข Regulatory Framework for Drug Delivery Systems: An overview of the global regulatory landscape, including regulations and guidelines for drug delivery systems from international agencies such as the FDA, EMA, and ICH.
โข Quality Management Systems in Drug Delivery: An exploration of quality management principles and their application in drug delivery manufacturing, including ISO 13485 and FDA Quality System Regulation.
โข Design Controls for Drug Delivery Devices: A review of design control requirements for drug delivery devices, including user needs, design inputs, outputs, and verification and validation activities.
โข Risk Management in Drug Delivery: An examination of risk management principles, including ISO 14971 and FDA guidance, and their application in drug delivery device design and manufacturing.
โข Labeling and Packaging Requirements for Drug Delivery Systems: A discussion of labeling and packaging requirements, including regulatory requirements, content, and format.
โข Clinical Evaluation and Post-Market Surveillance for Drug Delivery Devices: An overview of clinical evaluation and post-market surveillance requirements for drug delivery devices, including clinical investigation, performance evaluation, and post-market clinical follow-up.
โข Supply Chain Management and Distribution for Drug Delivery Systems: An exploration of supply chain management and distribution requirements, including GDP, GMP, and GDP guidelines.
โข Data Integrity and Cybersecurity for Drug Delivery Systems: A discussion of data integrity and cybersecurity requirements for drug delivery systems, including 21 CFR Part 11, Annex 11, and NIST guidelines.
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