Global Certificate in Medical Printing Regulations
-- ViewingNowThe Global Certificate in Medical Printing Regulations is a comprehensive course that provides learners with in-depth knowledge of the complex regulatory landscape in medical printing. This course highlights the importance of compliance with medical regulations, such as FDA, MDR, and IVDR, to ensure patient safety and avoid legal complications.
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⢠Global Medical Printing Standards: Overview of international standards for medical printing, including ISO 13485 and FDA regulations.
⢠Regulatory Compliance: Understanding the legal and ethical requirements for medical printing, including documentation and record-keeping.
⢠Quality Control: Implementing best practices for quality assurance and control in medical printing, including risk management and continuous improvement.
⢠Materials and Supplies: Selection and management of materials and supplies for medical printing, including raw materials, inks, and substrates.
⢠Equipment and Maintenance: Procurement, operation, and maintenance of equipment for medical printing, including printing presses, cutting machines, and packaging equipment.
⢠Labeling and Packaging: Design and production of labels and packaging for medical devices, including UDI (Unique Device Identification) requirements.
⢠Supply Chain Management: Management of suppliers, distributors, and logistics for medical printing, including vendor qualification and management.
⢠Training and Education: Development and implementation of training programs for medical printing personnel, including GMP (Good Manufacturing Practices) and regulatory compliance training.
⢠Audits and Inspections: Preparation for and management of audits and inspections by regulatory authorities, including FDA inspections and notified body audits.
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