GMP Publications - Code of Federal Regulation Handbooks by the FDA

1 Day Drug GMP Bootcamp - US - 20 free GMP Master Handbooks

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You have the books, now get the training!

GMP Publications Special - $3,495.00 - All Inclusive 1 day bootcamp seminar - Includes Course Binders, Handbooks, and Certificates for up to 20* Attendees, Travel, Hotels and Expenses - Conducted by The Auditing Group.

- For more details, call 856-810-7331
- *Additional attendee binders (over 20) will be charged $25.00 USD each.

 

 

Untitled Document
Day 1 Topics

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 Charter

21 CFR Parts 210/211 Drug GMPs

  • GMPs - The Basics
  • The Predicate Rules - Basics
  • Attitudes and Behavior Patterns
  • 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
  • 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
  • Complaint Handling and Customer Satisfaction Program

21 CFR Part 820 Predicate Status Rules

 


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