Certificate in Regulatory Compliance for Medical Printing
-- ViewingNowThe Certificate in Regulatory Compliance for Medical Printing is a vital course for professionals seeking expertise in the highly regulated medical printing industry. This program covers essential compliance knowledge, focusing on FDA regulations, quality systems, and documentation requirements.
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โข Introduction to Regulatory Compliance: Understanding the importance of regulatory compliance in medical printing, common regulations and guidelines (FDA, HIPAA, etc.)
โข Medical Device Classification: Learning the classification system for medical devices, including Class I, II, and III devices
โข Labeling and Packaging Requirements: Compliance with labeling and packaging requirements for medical devices, including UDI (Unique Device Identification) system
โข Quality System Regulation: Understanding the requirements for a quality system regulation (QSR) and how to implement it
โข Risk Management: Implementing risk management in medical device design, development and production
โข Medical Printing Process Control: Understanding and controlling the medical printing process, including design control, process validation and documentation
โข Inspection and Audit Preparation: Preparing for inspections and audits by regulatory agencies, including FDA inspections
โข Adverse Event Reporting: Learning how to report adverse events and implementing a system for reporting and tracking adverse events
โข Compliance Maintenance: Understanding how to maintain compliance, including ongoing monitoring and continuous improvement
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