1 Day Drug GMP

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 - 21 CFR Part 820 Predicate Status Rules

  • 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