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Regulatory Focus for Medical Devices Manufacture
Upcoming Events & Interviews
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Aim: To provide the essential concepts of regulations and codes of practice that governs the manufacture of medical devices both nationally and internationally. To develop a broad understanding of scope of the Good Manufacturing Practices and quality system elements applicable to devices. Date: 14 – 16 December 2015

Day 1

AM ► Understanding the application of QSIT, 21CFRpart820 and ISO13485

PM ► Introduction to Supplier Management and Control

Day 2

AM ► Manufacturing Controls and SPC

PM ► Medical Device Validation Practices

Day 3

AM ► Introduction to Design Controls

PM ► Application of RCA techniques and CAPA System



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