Global Certificate in Combination Product Documentation Compliance

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The Global Certificate in Combination Product Documentation Compliance course is a comprehensive program designed to meet the growing industry demand for experts in combination products. This course emphasizes the importance of regulatory compliance and provides learners with the necessary skills to excel in this specialized field.

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이 과정에 대해

It covers critical topics such as design control, risk management, and labeling, ensuring that learners gain a deep understanding of the regulations and guidelines that govern combination products. By earning this certification, learners demonstrate their expertise in combination product documentation compliance, making them highly attractive to employers in the medical device, pharmaceutical, and biotech industries. This course equips learners with the essential skills needed for career advancement, providing them with a solid foundation for success in this rapidly evolving field.

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과정 세부사항

• Combination Product Regulations: Overview of global regulations and guidance for combination products, including FDA, EMA, and ICH guidelines.
• Quality Systems and Compliance: Design control, risk management, change control, and document management for combination products.
• Clinical and Non-clinical Data Requirements: Collection, analysis, and reporting of clinical and non-clinical data to support combination product approvals.
• Labeling and Promotional Materials Review: Compliance with labeling requirements, including instructions for use, and promotional materials review and approval process.
• Pharmacovigilance and Post-Market Surveillance: Adverse event reporting, signal detection, and risk management in post-market surveillance.
• Combination Product Design and Development: Design and development considerations for combination products, including software, mechanical, and electronic components.
• Combination Product Testing and Validation: Testing and validation strategies for combination products, including performance, stability, and sterility testing.
• Combination Product Submissions and Approvals: Preparation and submission of combination product applications, including pre-market approval (PMA), biologics license application (BLA), and new drug application (NDA).
• Combination Product Inspections and Audits: Preparation for and handling of FDA and other regulatory authority inspections and audits.

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