GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs

10Part11.210.210.jpg
1-933734-52-3

US FDA Title 21 CFR PARTS 11, 210/211 and 820 Pocket Guide

3 popular regulations in an easy to carry pocket handbook.

  • US FDA Title 21 CFR Part 11
  • Part 11 Electronic Records; Electronic Signatures
  • Scope and Application - August 2003

This regulation pertains to electronic records, electronic signatures and handwritten signatures executed to electronic records. This part also applies to records in electronic form that are created, modified, maintained, archived, retrieved or transmitted, under any records requirements set forth in agency regulations.

Also includes Scope and Application 2003 - FDA Interpretation of Part 11 Requirements.

US FDA Title 21 CFR Parts 210/211 Good Manufacturing Practices

  • The regulations set forth in parts 210/211 contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.
  • US FDA Title 21 CFR Part 820 Quality Systems Regulation The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.

Quantity   1 - 50     51 - 99     100 - 249     250 - 499     500 - 999     1000+  
Price $8.90 $8.60 $6.80 $6.70 $6.50 $5.90

Quantity   


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

Banner-Monthly-200811-1-266
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
  • 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-->