GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 11, 210/211 - Electronic Records with Drug GMPs-ENGLISH/SPANISH

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The GMP Parts 11 Electronic Records; Electronic Signatures along with the Drug GMPs Parts 210 and 211 Current Good Manufacturing Practice for Finished Pharmaceuticals regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.

  • 21 CFR Part 11 Electronic Records; Electronic Signatures
  • Part 11 Scope and Application - August 2003
  • 21 CFR Parts 210/211 Drug GMPs

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.



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2 Day Drug GMP Boot Camp - November AC

Don't just get the books! Get the Training!

2 Day Pharmaceutical Drug GMP Boot Camp
(21 CFR Part 211 with ICH Q7 API)

'cGMP Training from the Auditor's Perspective'

5 - 6 November, 2018 - Atlantic City, New Jersey


(For Medical Device Boot Camps Click Here)

$995.00 USD - Sign-up Today!

Marriott Courtyard
Atlantic City, NJ

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 (Satisfies the annual GMP Training Requirements)

- 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 Parts 210/211 Drug GMPs - (with ICH Q7 - API Correlations)

  • GMPs - The Basics - Quality Definitions, CAPA, Deviations, Non-Conformance
  • Organizational & Management Responsibilities
  • Document Control Program
  • Employee Orientation, Quality Awareness, and Job Training
  • Plant Safety and Security
  • Internal Quality/GMP Training Session Program
  • Quality Cost Program
  • Design Control
  • Facility Design and Layout
  • Environmental Control Program
  • Facility Maintenance and Good
  • Housekeeping Program
  • Outside Contractor Control Program
  • Equipment Design and Placement
  • Equipment Identification
  • Equipment Maintenance & Cleaning
  • Measurement Equipment Calibration Program
  • Equipment Qualification Program
  • Material/Component Specification and Purchasing Control
  • Material/Component Receipt, Inspection, Sampling, and Laboratory Testing
  • Material Component Storage and Handling
  • Inventory Control Program Vendor (Supplier) Control Program
  • Material/Component/Label Verification, Storage, and Handling
  • Equipment/Line/Area Cleaning, Preparation, and Clearance
  • Operational Process Validation and Production Change Order Control

 

Day 2 Topics

- Breakfast

- 21 CFR Parts 210/211 Drug GMPs (Cont.)

  • In-Process Inspection, Sampling, and Laboratory Control
  • Reprocessing/Disposition of Materials
  • Finished Product Verification, Storage, and Handling
  • Finished Product Inspection, Sampling, Testing, and Release for Distribution
  • Complaint Handling and Customer Satisfaction Program
  • Operational Process Validation and Production Change Order Control
  • In-Process Inspection, Sampling, and Laboratory Control
  • Reprocessing/Disposition of Materials
  • Finished Product Verification, Storage, and Handling
  • Finished Product Inspection, Sampling, Testing, and Release for Distribution
  • Distribution Controls
  • Marketing Controls

- Lunch

- Recall and Traceability

- cGMP for Sterile Drug

- ICH Q9 Quality Risk Management

- ICH Q10 Pharmaceutical Quality System

- cGMP for Phase 1 Clinical

- Questions and Answers

 

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