GMP Publications - Code of Federal Regulation Handbooks by the FDA

Drug & Device GMP Desk Reference Set


End of Year Special! Complete 2 Book GMP Desk Reference Set - $49.95 per set (regularly $69.90)

International GMP Master Guide

Specifically designed for Drug Manufacturers, with over 900 pages of GMP Guidance and Regulations to ensure your compliance is up to date! Includes US, EU, ICH, Can. & Japanese Guidance and Regulations.

  • All of the US Drug GMP Regulations
  • European GMP Regulations
  • ICH Q7, 8, 9 and 10 Guidance
  • Canadian GMPs GUI-0001 2018
  • Auditor's Checklist Parts 11, 211 & ICH Q7
  • Japanese GMPs
  • Added Chinese GMPs Decree 79 (English)

Medical Device Master GMP Guide

Specifically designed for Device Manufacturers, with over 900 Pages of Guidance and Regulations for the Medical Device Industry Medical Device Manual - Includes US and EU Regulations.

  • All of the US Medical Device Regulations
  • Quality System Inspection Technique (QSIT)
  • PMA/510k Guidance
  • New EU MDR 2017/745 Regulations
  • Added QSR Auditor Checklist with ISO 13485 References
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8-Hour GMP QMS Webinar Training

Calendar:

  • December 28, 2020
  • January 25, 2021
  • February 23, 2021
  • March 23, 2021
  • April 27, 2021
  • May 25, 2021
  • June 22, 2021
  • July 27, 2021

GMP QMS 101 The Basics - The required GMP Training for all employees who operate under Title 21 Compliance Requirements.

  • GMP - What is cGMP and the GMP Lifestyle?
  • The Agency History and Objectives
  • Roles and Responsibilities
  • The 10 Principals of GMP
  • Good Documentation Practices (GDocP)
  • Facility Management
  • The History of GMP, the Agency Inspections and 483s
  • Warning Letter Reviews

21 CFR Part 11 Electronic Records

  • 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)
    - - Validation
    - - Copies of records
    - - Protection of records
    - - Limiting system access
    - - Audit trails
    - - Operational system checks
    - - Authority checks (h) Device checks
    - - Education, Training, Experience
    - - Policies and Procedures
    - - Systems documentation
    • Scope and Application Risk Analysis - Determine Which Systems Need to be Validated
    • Steering Committee and Part 11 Initiatives

Good Auditing Practice

  • The Auditor's Basics 101 'From the Auditor's Perspective'
  • The 5 Basic Binders
  • The Quality Manual
  • IT Strategy Plan
  • Standard Operating Procedures
  • Validation Documentation
  • Drug/Device Documentation

The QMS Basics

- - CAPA
- - Non-Conformance
- - Change Control
- - Deviations
- - Out of Specifications / Out of Trend
- - Complaints
- - Recalls
- - Product Traceability
- - Audit - Internal, Agency, Customers and External Audit
- - Vendors, Suppliers, Contractors and Consultants
- - Basic Risk Management
- - Training Program

Questions and Answers

 

Includes:
- - Binders (shipped free for US Customers)
- - Handbooks
- - Certificate of Attendance (Completion)

Quantity
example: 211, ISBN, Drug, GMP, Etc. - Press Enter
GMP Training Mix and Match Clinical Manufacturing Handbook End of Year Special Featured Publication GCP Device GMP GCP-DRUG Featured Publication
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