Global Certificate in Combination Product Documentation Compliance

• 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.