ISO 22716 Internal Auditor

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Course Content

Module 1: Introduction to ISO 22716 & Core Concepts

Welcome and Course Orientation
Introduction to ISO 22716:2007
Key Terms and Definitions (Part 1)
Key Terms and Definitions (Part 2)
ISO 22716 and Regulatory Compliance
Core Principles of GMP & Documented Information
Module 1 Principal Test

Module 2: GMP Core Elements: Personnel, Premises, & Equipment

Clause 3: Personnel – Overview & Competence
Clause 3: Personnel – Training, Hygiene & Visitors
Clause 4: Premises – Overview & Design
Clause 4: Premises – Environmental Controls & Utilities
Clause 4: Premises – Maintenance & Cleaning
Special Focus: Water for Production
Clause 5: Equipment – Overview & Suitability
Clause 5: Equipment – Calibration & Maintenance
Module 2 Principal Test

Module 3: Materials & Production Introduction

Module 4: Quality Control & Management Systems Intro

Module 5: Introduction to Internal Auditing & Principles

Module 6: Audit Planning & Preparation Intro

Module 7: Conducting On-Site Audits Intro

Module 8: Audit Reporting & Follow-up Intro

Module 9: Exam Preparation & Final Assessment

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