GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR Parte 117 - cGMPs for Human Food - SPANISH

117Cover60Percent
978-1-935131-73-1

Spanish PARTE 117—Prácticas Actuales De Buena Fabricación, Análisis De Peligro Y Controles Preventivos Basados En Riesgo Para La Alimentación Humana

 

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GMP QMS 101 The Basics - The required GMP Training for all employees who operate under Title 21 Compliance Requirements.

  • GMP - What is cGMP and the GMP Lifestyle?

  • The Agency History and Objectives

  • Roles and Responsibilities

  • The 11 General Orders of GMP

  • Good Documentation Practices (GDocP)

  • Facility Management

  • The History of GMP, the Agency Inspections and 483s

  • Warning Letter Reviews

21 CFR Part 11 Electronic Records

  • 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)

    - - Validation

    - - Copies of records

    - - Protection of records

    - - Limiting system access

    - - Audit trails

    - - Operational system checks

    - - Authority checks (h) Device checks

    - - Education, Training, Experience

    - - Policies and Procedures

    - - Systems documentation

    • Scope and Application Risk Analysis - Determine Which Systems Need to be Validated

    • Steering Committee and Part 11 Initiatives

Good Auditing Practice

  • The Auditor's Basics 101 'From the Auditor's Perspective'

  • The 5 Basic Binders

  • The Quality Manual

  • IT Strategy Plan

  • Standard Operating Procedures

  • Validation Documentation

  • Drug/Device Documentation

The QMS Basics

- - CAPA
- - Non-Conformance
- - Change Control
- - Deviations
- - Out of Specifications / Out of Trend
- - Complaints
- - Recalls
- - Product Traceability
- - Audit - Internal, Agency, Customers and External Audit
- - Vendors, Suppliers, Contractors and Consultants
- - Basic Risk Management
- - Training Program

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