GMP Publications - Code of Federal Regulation Handbooks by the FDA

US and Canadian GMPs with ICH Q7, Q8(R2), Q9, Q10

US11.210.211.CanadaGMPs.ICHQ7.8.9.jpg
978-1-935131-34-2

US FDA Title 21 CFR Parts

21 CFR Part 11 - Electronic Records/Electronic Signatures (ERES)
21 CFR Part 210/211 - cGMP in Manufacturing, Processing, Packaging or Holding of Drugs and Finished Pharmaceuticals

Canadian GMP - GUI-0001

International Conference on Harmonisation Regulations

ICH Q7 - Good Manufacturing Practice guide for API
ICH Q8(R2) - Pharmaceutical Development
ICH Q9 - Quality Risk Management
ICH Q10 - Pharmaceutical Quality System














Quantity   1 - 99     100 - 249     250 - 499     500 - 999     1000+  
Price $19.50 $15.95 $12.95 $9.50 $8.90

Quantity   


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

2 Day Drug GMP Boot Camp Conference - June 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'

18 - 19 June, 2018 - Atlantic City, New Jersey


$995.00 USD - Sign-up Today!

Sheraton Atlantic City Convention Center Hotel
2 Convention Boulevard, Atlantic City, NJ 08401
www.sheratonatlanticcity.com

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

Quantity
example: 211, ISBN, Drug, GMP, Etc. - Press Enter
Featured Publication Mix and Match End of Year Special New Books Featured Publication GMP Boot Camp 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-->