GMP Publications - Code of Federal Regulation Handbooks by the FDA

Medical Device QSIT Manual with 11, 803, 806, 820 and 821

10Part11.803.806.820.821.jpg
978-1-935131-10-6

US FDA Title 21 CFR Parts

Part 11 - Electronic Records/Electronic Signatures (ERES)
Part 803 - Medical Device Reporting
Part 806 - Medical Devices; Reports of Corrections & Removals
Part 820 - Quality Systems Regulations
Part 821 - Medical Device Tracking Requirements

Quality System Inspection Technique (QSIT) - Guide to Inspections of Quality Systems August 1999




















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2 Day Device GMP Boot Camp - 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


(For Drug GMP Boot Camps Click Here)

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Atlantic City

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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