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Part 11 and Systems Validation:

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
21 CFR Parts 210/211 Drug GMPs (Cont)

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

ICH Q7 - GMPs for Active Pharmaceutical Ingredients:

Introduction
Quality Management
Personnel
Buildings and Process Equipment
Documentation and Records
Materials Management
Production and In-Process Controls
Packaging and Identification
Labeling of APIs and Intermediates
Storage and Distribution
Laboratory Controls
Validation
Change Control
Rejection and Re-Use of Materials
Complaints and Recalls
Contract Manufacturers (Including Laboratories)

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