GMP Publications - Code of Federal Regulation Handbooks by the FDA

Clinical Master Reference Guide

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978-1-935131-27-4

The 600+ page GCP Master Handbook is a complete reference library for the clinical professional. This handbook comes in a easy to carry 4.5" x 7.5" pocket size booklet for quick access to standards and references.

Includes:

US FDA Title 21 CFR Parts

  • Part 11 Electronic Records
  • Part 50 Protection of human subjects
  • Part 54 Financial disclosure by clinical investigators
  • Part 56 Institutional Review Boards
  • Part 312 Investigational New Drug Application
  • Part 314 Application to the FDA to Market a New Drug
  • Part 316 Orphan Drugs
  • Part 320 Bioavailability and bioequivalence requirements
  • Program 7348.810 - Bioresearch Monitoring Sponsors, Contract Research Organizations and Monitors
  • Program 7348.811 Bioresearch Monitoring: Clinical Investigators

US FDA Guidance Documents

  • Part 11 Scope and Application August 2003
  • Computerized Systems Used In Clinical Investigation May 2007
  • Institutional Review Boards Frequently Asked Questions (FAQ)
  • Guideline for the Monitoring of Clinical Investigations
  • CGMP for Phase 1 Investigational Drugs July 2008

International Conference on Harmonisation Regulations

  • ICH E2A Clinical Safety Data Management
  • ICH E2E Pharmacovigilance Planning
  • ICH E6 (R2) Good Clinical Practice
  • ICH E8 General Considerations for Clinical Trials

EU & Helsinki Directives

  • Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects
  • European Clinical Trials Directive (2001/20/EC)
  • Guidelines for good clinical practice (2005/28/EC)

GMP Publications Audit Check Lists

  • Checklist for GCP Systems Gap Analysis
  • Checklist for Computerized Systems and Part 11

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8-Hour GMP QMS Webinar Training

Calendar:

  • 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)

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