Executive Development Programme in Drug Delivery Compliance
-- ViewingNowThe Executive Development Programme in Drug Delivery Compliance is a certificate course designed to provide learners with critical insights into the regulatory and compliance aspects of drug delivery systems. With the pharmaceutical industry increasingly focusing on innovative drug delivery technologies, there is a growing demand for professionals who understand the complex compliance landscape.
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⢠Regulatory Framework for Drug Delivery Systems: Understanding the legal and regulatory landscape governing drug delivery compliance, including FDA regulations and guidelines.
⢠Quality Management Systems: Overview of quality management systems (QMS) and their role in ensuring compliance in drug delivery, including ISO 13485 and FDA Quality System Regulation.
⢠Design Controls and Risk Management: Best practices for designing and developing drug delivery systems, including risk management strategies and design control processes.
⢠Good Manufacturing Practices (GMPs): Overview of GMPs and their role in ensuring compliance in drug delivery manufacturing, including cGMP regulations and guidelines.
⢠Labeling, Packaging, and Distribution: Understanding the requirements for labeling, packaging, and distribution of drug delivery systems, including UDI regulations and labeling guidelines.
⢠Clinical Trials and Post-Market Surveillance: Overview of clinical trials and post-market surveillance for drug delivery systems, including clinical trial design and post-market surveillance strategies.
⢠Data Integrity and Compliance: Best practices for ensuring data integrity and compliance in drug delivery, including data management and data security strategies.
⢠Change Management and Continuous Improvement: Overview of change management and continuous improvement strategies for drug delivery systems, including risk-based approaches and quality by design principles.
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