GMP Publications - Code of Federal Regulation Handbooks by the FDA

Drug & Device GMP Desk Reference Set


Purchase Both as a complete desk reference set!

Regularly sold at $34.95 each, now get both for $ 49.90
Over 1900 pages of Regulations and Guidance to complete your library

 

Enhance your order and Get  50 Free Sets! 

With a Combination GMP Audit and Training Seminar!

 


US FDA Title 21 CFR Parts

- Part 11 Electronic Records; Electronic Signatures with scope & Application
- Part 11 - Auditor's Check List
- Part 58 - Good Laboratory Practice
- Part 111 - Dietary Supplements GMPs
- Parts 210/211 Drug GMPs
- Parts 210/211 Drug GMPs - Auditor's Check List
- Part 820 Quality Systems Regulations
- Part 820 QSR - Auditor's Check List

Guidance

- ICH Q7 Active Pharmaceutical Ingredients (APIs)
- ICH Q7 - Auditor's Check List
- ICH Q8 - Pharmaceutical Development
- ICH Q9 - Quality Risk Management
- ICH Q10 - Pharmaceutical Quality System
- EU GMPs Chapter 1 – 9
- Canadian GMPs 2009 Edition GUI-0001
- Japanese GMPs

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
- EU GMPs - Chapter 1 - 9
- Annex 11 Computerized Systems
- Annex 15 Qualification and Validation
- ICH Q8(R2) - Pharmaceutical Development
- ICH Q9 - Quality Risk Management
- ICH Q10 - Pharmaceutical Quality System
- General Principles of Software Validation
- 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
           

 

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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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