GMP Publications - Code of Federal Regulation Handbooks by the FDA

Medical Device Quality Systems Manual with 11, 820, QSR Audit Checklist, 7382.845 with QSIT

MedDeviceQualitySysMan.11.820.Cklist.QSIT.7382.845.jpg
QSM/QSIT

The GMP Quality Management System Regulations address issues including:

  • Recordkeeping,
  • Personnel Qualifications,
  • Sanitation,
  • Cleanliness,
  • Facility Management
  • Equipment
  • Verification,
  • Process Validation, 
  • Complaint Handling,
  • Recalls,
  • CAPA, and
  • Device Reporting
  • and much more...

Compiled and developed by John Cuspilich, Sr. Auditor for The Auditing Group.

GMP Publications Quality Compliance Publications Helping Companies Meet and Exceed FDA and Total Quality Management Standards.

This is a great training and information tool to provide all employees with the CFR requirements for the Food, Drug, Medical Device, Cosmetic, Healthcare, Electronic Records and Good Laboratory Practice.

FDA Title 21 CFR Parts and Guidance

  • 21 CFR Part 11 - Electronic Records/Electronic Signatures (ERES) with Scope and Application
  • 21 CFR Part 820 - Quality Systems Regulations
    QSR Audit Checklist
  • Medical Device Quality Systems Manual
  • Quality System Regulation Auditor's Self Assessment Check List
  • QSIT - Quality Systems Inspection Techniques
  • US FDA 7382.845 - Inspection of Medical Device Manufacturers

For persons who purchased this item, you may also be interested in: On-Site Medical Device Boot Camps!

 

 

 

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2 Day Device GMP Boot Camp Conference - June AC

Don't Just Get the Books!  Get the Training!

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

GMP Training from the Auditor's Perspective

20 - 21 June, 2018 - Atlantic City, New Jersey


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Sheraton Atlantic City Convention Center Hotel
2 Convention Boulevard, Atlantic City, NJ 08401
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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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