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Location

2 Day Drug / Dietary Supplement Boot Camp

Includes Travel, hotels, expenses, binders, handbooks and Certificates for up to 10 Attendees (additional addendees will be charged $25.00USD).
Secure now or send checks to: The Auditing Group, Inc.,
PO Box 1696, Medford, NJ 08055
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


Day 2 Topics

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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