GMP Publications - Code of Federal Regulation Handbooks by the FDA

GMP Medical Device Master Reference Guide


 

Over 900 Pages of Guidance and Regulations for the Medical Device Industry Medical Device Manual

Includes:

US FDA Title 21 CFR Parts

21 CFR Part 11 - Electronic Records; Electronic Signatures
21 CFR Part 801 - Labeling - Medical Device
21 CFR Part 803 - Medical Device Reporting
21 CFR Part 806 - Medical Devices; Reports of Corrections and Removal
21 CFR Part 807 - Estab. Reg. and Device Listing for Manuf. and Initial Importers of Devices
21 CFR Part 809 - In-Vitro Diagnostic Products
21 CFR Part 810 - Medical Device Recall Authority
21 CFR Part 812 - Investigational Device Exemptions
21 CFR Part 814 - Premarket Approval of Medical Device
21 CFR Part 820 - Quality Systems Regulations
21 CFR Part 821 - Medical Device Tracking Requirements
21 CFR Part 822 - Postmarket Surveillance
21 CFR Part 830 - Unique Device Identification
 
Guidance

Medical Device QSIT Manual
PMA Premarket Approval and 510 (k) Guidance
Inspection of Medical Device Manufacturers Program 7382.845
Annex 11 Computerized Systems
Annex 15 Qualification and Validation
ICH Q9 - Quality Risk Management
ICH Q10 - Pharmaceutical Quality System
Canadian Medical Device Regulations - SOR/98-282
98/79/EC In Vitro Diagnostic Medical Devices
93/42/EEC Medical Device Directive Updated 2007/47/EC September 2007
            

 

Quantity   1 - 99     100 - 249     250 - 499     500 - 999     1000+  
Price $34.95 $24.95 $17.95 $15.95 $12.95

Quantity   


Upgrade your order or view other GMP Products that you may be interested in:

2 Day Device GMP Boot Camp Conference - November 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

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


$995.00 USD - Sign-up Today!

Courtyard Marriott
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

Quantity
example: 211, ISBN, Drug, GMP, Etc. - Press Enter
Mix and Match End of Year Special New Books Featured Publication GMP Boot Camp GCP Device GMP GCP-DRUG Featured Publication
  • Guaranteed Lowest Price
  • Quantity Discounts Available
  • Always Current, Up-To-Date
  • Company Logos Available
  • Special Customizations
  • Pocket-sized 3.75" x 6.25"
  • Prep for FDA & Client Audits
  • Employee Training & Reference
  • Promotional "giveaways"
  • Tradeshows and meetings

Our Valued Clients










Return to the GMP Publications home page View your shopping cart-->