ISO 22716 Lead Auditor Training - Canada

ISO 22716 Lead Auditor Training Course Outline

Module 1: Introduction to ISO 22716

• Introduction
• Scope
• Terms and Definitions

Module 2: Good Manufacturing Practices (GMP)

• What is GMP?
• Components of GMP
• GMP Principles
• Regulations and Standards
• How to Comply with Guidelines?

Module 3: Personnel

• Principle
• Organisation
• Key Responsibilities
• Training
• Personnel Hygiene and Health
• Visitors and Untrained Personnel

Module 4: Premises

• Principle
• Types of Area
• Space
• Flow
• Floors, Walls, Ceilings, Windows
• Washing and Toilet Facilities
• Lighting
• Ventilation
• Pipework, Drains, and Ducts
• Cleaning and Sanitisation
• Maintenance
• Consumables
• Pest Control

Module 5: Equipment

• Principle
• Equipment Design
• Installation
• Calibration
• Cleaning and Sanitisation
• Maintenance
• Consumables
• Authorisations
• Back-Up Systems

Module 6: Raw Materials and Packaging Materials

• Principle
• Purchasing
• Receipt
• Identification and Status
• Release
• Storage
• Re-Evaluation
• Quality of Water Used in Production

Module 7: Production

• Principle
• Manufacturing Operations
• Packaging Operations

Module 8: Finished Products

• Principle
• Release
• Storage
• Shipment
• Returns

Module 9: Introduction to Internal Auditor

• Who is Internal Auditor?
• Duties of Internal Auditor
• Soft and Hard Skills for Internal Auditor
• Internal Vs External Auditor

Module 10: Internal audit

• Principle
• Approach
• Follow-Up

Module 11: GMP Audit

• What is GMP Audit?
• What is Involved in the GMP Audit Process?
• How to Prepare for a Typical GMP Audit?
• Hosting GMP Audit
• Common Mistakes Made During GMP Audits
• GMP Auditing Best Practices

Module 12: GMP Supplier Audit

• Conducting a GMP Supplier Audit
• Supplier Audit Checklist
  • Quality Policy
  • Training and Accountability
  • General Organisation
  • Supply Access
• Steps to Successfully Perform the GMP Supplier Audit

Module 13: Quality Control Laboratory

• Principle
• Test Methods
• Acceptance Criteria
• Results
• Out-of-Specification Results
• Reagents, Solutions, Reference Standards, Culture Media
• Sampling
• Retain Sample

Module 14: Treatment of Product

• Rejected Finished Products, Bulk Products, Raw Materials, and Packaging Materials
• Reprocessed Finished Products and Bulk Products

Module 15: Wastes

• Principle
• Types of Waste
• Flow
• Containers
• Disposal

Module 16: Subcontracting

• Principle
• Types of Subcontracting
• Contract Giver
• Contract Acceptor
• Contract

Module 17: Implementing GMP

• Quality Management
• Sanitation and Hygiene
• Building and Facilitation
• Equipment
• Raw Materials
• Personnel
• Validation and Qualification
• Complaints
• Documentation and Recordkeeping

Module 18: Lead Auditor

• Who is Lead Auditor?
• Roles and responsibilities of Lead Auditor
• Audit Report
• Types of Audit Process

Module 19: Deviations

• Deviations Overview

Module 20: Complaints and Recalls

• Principle
• Product Complaints
• Product Recalls

Module 21: Change Control

• Change Control Overview

Module 22: Structured GMP Audit

• Customer Communication
• Auditor Selection
• Auditor Planning
• Audit Preparation
• Audit Execution
• Audit Report

Module 23: Documentation

• Principle
• Type of Document
• Writing, Approval, and Distribution
• Revision
• Archiving

Who should attend this ISO 22716 Lead Auditor Training Course?

The ISO 22716 Lead Auditor Training Course is specifically designed for professionals, managers, and individuals who aspire to become Lead Auditors for Good Manufacturing Practices (GMP) in the cosmetics industry, as outlined in the ISO 22716 standard. This course is beneficial for various professionals including:

• Quality Assurance Managers
• Regulatory Affairs Managers
• Cosmetics Production Managers
• Internal Auditors
• Quality Control Specialists
• Compliance Managers
• Environmental Health and Safety (EHS) Managers
• Product Testing and Validation Specialists

Prerequisites for the ISO 22716 Lead Auditor Training Course

There are no formal prerequisites for attending this ISO 22716 Lead Auditor Training Course.

ISO 22716 Lead Auditor Training Course Overview

ISO 22716 provides cosmetic products' manufacturing, control, storage, and shipment guidelines. The purpose of these guidelines is to offer advice on Good Manufacturing Practices (GMP) for cosmetic products. These guidelines provide valuable organisational guidance on controlling the administrative, technical, and human variables impacting product quality.

This training aims to provide learners with a detailed knowledge of cosmetic goods manufacturing practices and the guidelines to implement these practices within an industry. Individuals with fantastic auditing skills and a proper understanding of guidelines will gain higher designations in globally recognised organisations and expand their professional network quickly.

The Knowledge Academy’s 5-day ISO 22716 Lead Auditor Training course provides delegates with a comprehensive knowledge of cosmetic products manufacturing and how to audit these practices. During this training, delegates will learn about GMP supplier audits to reduce company production costs. They will also learn about the quality control laboratory to ensure the relevant and necessary controls within its activities. Our highly skilled and knowledgeable instructor with years of experience teaching ISO courses will conduct this training.

Course Objectives

• To ensure that controlled and stored products to acceptance criteria
• To take and prepare the samples from the set of related operations
• To reduce undesirable micro-organisms on inert contaminated surfaces
• To define the quantity of raw material or product issued from one process
• To perform the assigned responsibilities and activities in a given time frame
• To determine quality activities and related results comply with arrangements

After attending this training, delegates will be able to obtain cosmetic products that meet the defined characteristics in the ISO guidelines. They will also be able to validate the effectiveness of standard operating procedures and conduct GMP audits regularly. 

What’s included in this ISO 22716 Lead Auditor Training Course?

• ISO 22716 Lead Auditor Examination
• World-Class Training Sessions from Experienced Instructors
• ISO 22716 Lead Auditor Certificate
• Digital Delegate Pack

ISO 22716 Lead Auditor Exam Information

To achieve the ISO 22716 Lead Auditor Training, candidates will need to sit for an examination. The exam format is as follows: 

• Question Type: Multiple Choice 
• Total Questions: 30 
• Total Marks: 30 Marks 
• Pass Mark: 50%, or 15/30 Marks 
• Duration: 40 Minutes