GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 11, 820 QSR and 830 UDI

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US FDA Title 21 CFR Parts 11 Electronic Records, 820 QSR and 830 Unique Device Identification Pocket Guide

The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.

The UDI regulation is designed to help companies understand, identify and trace medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form.

These two requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act).

This part establishes basic requirements applicable to manufacturers of finished medical devices.











 

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- Breakfast and Opening Introductions

- GMP 101 The Basics

- 21 CFR Part 11 Basic Overview

  • 21 CFR Part 11 Definitions, System Types and Classifications
  • 21 CFR Part 11 Electronic Records; Electronic Signatures – Predicate Rule
  • Part 11.10 Sections a) - k)
    • (a) Validation
    • (b) Copies of records
    • (c) Protection of records
    • (d) Limiting system access
    • (e) Audit trails
    • (f) Operational system checks
    • (g) Authority checks (h) Device checks
    • (i) Education, Training, Experience
    • (j) Policies and Procedures
    • (k) Systems documentation
  • Risk Analysis - Determine Which Systems Need to be Validated
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- Lunch

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  • GMP Basics 101
  • Part 11 Overview
  • Scope and Definitions
  • Quality System Requirements
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  • Personnel
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  • Purchasing Controls
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  • Device labeling
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  • Records - General requirements
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  • Records - Complaint files
  • Servicing
  • Statistical Techniques

 

Day 2 Topics

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ISO 13485:2016 (with Comparisons with ISO 13485:2003 and 21 CFR Part 820)

  • Definitions
  • Quality Management System
    • Quality Manual
    • Medical Device File
    • Control of Documents
    • Control of Records
  • Management Responsibilities
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    • Planning
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    • Management Review
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    • Improvements

- Lunch - Warning Letters

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