GMP Publications - Code of Federal Regulation Handbooks by the FDA

GMP Publications - Code of Federal Regulation Handbooks by the FDA

Pharmaceutical - 25 GMP Handbooks and 8-hour GMP Webinar - $5,995.00 - More information

GMP Publications and Boot Camp

Pharmaceutical GMP Training and Handbooks:

GMP Handbooks and 8-hour GMP Training Package for 25 People.

Taught by the leading GMP Expert and Senior Auditor for The Auditing Group and GMP Boot Camps.

Focus on:

  • Basic GMP and QMS Overview
  • 21 CFR Part 11 Overview
  • 21 CFR Part 210/211 Drug GMPs

Turn-key training includes:

Basic Drug GMP 101 Overview:

2 hour GMP 101 The Basics (Satisfies the annual GMP Training Requirements)

  • GMP - What is cGMP and the GMP Lifestyle?
  • The Agency History and Objectives
  • Roles and Responsibilities
  • The 10 Principals of GMP
  • Writing Procedures
  • Facility Management
  • Agency Inspections and 483s
  • The 5 Basic Binders The Quality Manual
  • IT Strategy Plan
  • Standard Operating Procedures
  • Validation Documentation
  • Drug/Device Documentation

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

- Lunch

- 21 CFR Parts 210/211 Drug GMPs

  • 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
  • Complaint Handling and Customer Satisfaction Program
  • 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
  • Recall and Traceability
  • Corrective and Preventive Actions (CAPAs)
  • Process Validation Overview
  • Warning Letters and Case Studies

- Questions and Answers


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