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Location

1 Day General Labeling 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 - 1 hour

  • 21 CFR Part 11 Electronic Records; Electronic Signatures – Predicate Rule
  • 21 CFR Part 11 Electronic Records; Electronic Signatures – Scope and Application
  • Part 11.10 Sections (a)-(k)
  • Risk Analysis - Determine Which Systems Need to be Qualified

GMP Basics 101 - General GMP Concepts - Tailored to Labeling Manufacturing

  • 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
  • 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 101 Food labeling overview

21 CFR Part 201 Drug labeling overview,

21 CFR Part 701 Cosmetic labeling overview

21 CFR Part 801 Device labeling overview

Labeling Issues

 

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