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What Medical Device Manufacturers Can Learn from 21 CFR Part 211 Subpart D - Manufacturing Equipment Management
Introduction
Overview
Who should take this course
Learning Objectives
Definitions
Equipment Design, Size, and Location (Sect. 211.63)
Overview
Equipment Construction (Sect. 211.65)
Overview
Materials Used for Construction (Sect. 211.65)(a)
Substances Required for Operation (Sect. 211.65)(b)
Equipment Cleaning and Maintenance (Sect. 211.67)
Overview
Cleaning and Sterilization (Sect. 211.67)(a)
Written Procedures (Sect 211.67)(b)(l-6)
Recordkeeping (Sect. 211.67)(c)
Automatic, Mechanical, and Electronic Equipment (Sect. 211.68)
Overview
Calibration and Inspection (Sect. 211.68)(a)
Computer System Controls and Validation (Sect. 211.68)(b)
Checking Performance of Automated Equipment (Sect. 211.68)(c)
Filters (Sect. 211.72)
Overview
Thank You
Recordkeeping (Sect. 211.67)(c)
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