GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 820 - Quality System Regulations

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US FDA Title 21 CFR Part 820 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 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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2 Day Device GMP Boot Camp Conference - November AC

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2 Day Medical Device GMP 21 CFR Part 820 and
ISO 13485 (2003-2016) Conference

GMP Training from the Auditor's Perspective

8 - 9 November, 2018 - Atlantic City, New Jersey


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All Boot Camps Conferences Includes:

  • GMP Seminar Binders
  • Handbooks
  • Certificates of Attendance
  • Breakfast, Lunch and Refreshments
Day 1 Topics

- 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
  • Steering Committee and Charters

- Lunch

- 21 CFR Part 820 Device GMPs (With correlations to QSIT and ISO 13485)

  • GMP Basics 101
  • Part 11 Overview
  • Scope and Definitions
  • Quality System Requirements
  • Management responsibility
  • Quality audit
  • Personnel
  • Design Controls
  • Document Controls
  • Purchasing Controls
  • Identification and Traceability
  • Production and process controls
  • Inspection, measuring, and test equipment
  • Process validation
  • Acceptance Activities
  • Receiving, in-process, and finished device acceptance
  • Acceptance status
  • Nonconforming product
  • Corrective and preventive action
  • Device labeling
  • Device packaging
  • Handling
  • Storage
  • Distribution
  • Installation
  • Records - General requirements
  • Records - Device master record
  • Records - Device history record
  • Records - Quality system record
  • Records - Complaint files
  • Servicing
  • Statistical Techniques

 

Day 2 Topics

- Breakfast

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
    • Management Commitments
    • Quality Policy
    • Planning
    • Responsibilities, Authority and Communications
    • Management Review
  • Recourse Management
    • Provision of Resources
    • Human Resources
    • Infrastructure
    • Work Environment and Contamination Control
  • Product Realization
    • Planning of Product Realization
    • Customer Related Processes
    • Design and Development
    • Purchasing
    • Production and Service Provision
    • Control of Monitoring and Measuring Equipment
  • Measurement, Analysis and Improvement
    • Monitoring and Measurement
    • Control of Non-Conforming Product
    • Analysis of Data
    • Improvements

- Lunch - Warning Letters

- Validation and Qualification (Electronic Systems)

  • Definitions
  • GAMP Overview
  • Risk Analysis - Determine Which Systems Need to be Validated
  • Software / System Development Life Cycle (SDLC)
  • Compiling the Validation Master Plan (VMP)
  • Project Plan (PP) Development
  • User Requirement Specifications (URS)
  • Functional Requirement Specifications (FRS)
  • Design Specifications / Design Qualifications (DQ)
  • Installation Qualifications (IQ)
  • Operational Qualifications (OQ)
  • Performance Qualifications (PQ)
  • Auditing GxP Computer Systems

- Questions and Answers

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