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
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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. 

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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

You’ll also get access to the MyTKA Training Portal, which will be your go to hub for all your training.
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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  
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Experience live, interactive learning from home with The Knowledge Academy's Online Instructor-led ISO 22716 Lead Auditor Training. Engage directly with expert instructors, mirroring the classroom schedule for a comprehensive learning journey. Enjoy the convenience of virtual learning without compromising on the quality of interaction.

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Join dynamic live sessions featuring discussions, practical activities, and peer collaboration. Learn from ISO 22716 Lead Auditor Training industry experts and reinforce your knowledge with self-paced modules—plus, connect with professionals in your field.

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Learn ISO 22716 Lead Auditor Training through The Knowledge Academy’s Online Self-Paced Learning. This flexible and structured format supports your training goals and enables every professional to build skills with confidence.

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Experience the most sought-after learning style with The Knowledge Academy's ISO 22716 Lead Auditor Training. Available in 490+ locations across 190+ countries, our hand-picked Classroom venues offer an invaluable human touch. Immerse yourself in a comprehensive, interactive experience with our expert-led ISO 22716 Lead Auditor Training sessions.

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Boost your skills with our expert trainers, boasting 10+ years of real-world experience, ensuring an engaging and informative training experience

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Streamline large-scale training requirements with The Knowledge Academy’s In-house/Onsite ISO 22716 Lead Auditor Training at your business premises. Experience expert-led classroom learning from the comfort of your workplace and engage professional development.

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Monitor employees progress

The course know-how will help you track and evaluate your employees' progression and performance with relative ease

Package deals for ISO 22716 Lead Auditor Training

Our training experts have compiled a range of course packages on a variety of categories in ISO 22716 Lead Auditor Training, to boost your career. The packages consist of the best possible qualifications with ISO 22716 Lead Auditor Training, and allows you to purchase multiple courses at a discounted rate.

ISO 22716 Lead Auditor Training FAQs

What is ISO 22716?

ISO 22716 provides guidelines for Good Manufacturing Practices (GMP) in the cosmetic industry. It ensures that cosmetic products are consistently produced and controlled according to quality standards to minimise risks. These guidelines cover production, control, storage, and shipment processes.

What is ISO 22716 Lead Auditor?

An ISO 22716 Lead Auditor is trained to assess a company's compliance with the ISO 22716 guidelines. This certification prepares professionals to perform audits that ensure adherence to Good Manufacturing Practices (GMP) within the cosmetics industry.

What is the difference between ISO 22716 and ISO 13485?

ISO 22716 focuses on Good Manufacturing Practices for cosmetics, while ISO 13485 is a quality management system standard for medical devices. Each standard is industry-specific, addressing the unique requirements of their respective fields.

What is the difference between ISO 22716 and ISO 9001?

ISO 9001 is a general quality management standard applicable across various industries, while ISO 22716 specifically addresses Good Manufacturing Practices for the cosmetic industry. Both focus on quality but have different scopes and applications.

What year is ISO 22716?

ISO 22716 was first published in 2007. It remains a key standard in the cosmetics industry, providing essential guidelines for maintaining product safety and quality.

Are there any prerequisites to attending this ISO 22716 Lead Auditor Course?

There are no formal prerequisites, but having a basic understanding of the ISO 22716 guidelines and quality management systems would be beneficial for attendees of the ISO 22716 Lead Auditor Course.

Who should attend this ISO 22716 Lead Auditor Training Course?

This course is ideal for Quality Managers, Auditors, Regulatory Affairs Professionals, and anyone responsible for maintaining Good Manufacturing Practices (GMP) in the cosmetics industry.

What is the purpose of ISO 22716 guidelines?

The ISO 22716 guidelines aim to ensure the safety and quality of cosmetic products by establishing Good Manufacturing Practices (GMP) throughout the production process, from raw materials to distribution.

What are the principles of good manufacturing practices?

The key principles of GMP include maintaining hygiene, controlling processes, ensuring proper documentation, conducting regular audits, and continually improving practices to maintain product quality and safety.

What are the main benefits of good manufacturing practices?

The main benefits of GMP include ensuring product quality, enhancing customer confidence, minimising the risk of contamination, and ensuring compliance with regulatory standards.

What are the benefits of this ISO 22716 Lead Auditor Training?

This training equips delegates with the skills to perform effective audits, ensure compliance with GMP, improve internal processes, and enhance overall product quality in the cosmetics industry.

What will I learn in this ISO 22716 Lead Auditor Certification Training?

In this course, you will learn how to conduct audits in line with ISO 22716 guidelines, understand key audit principles, and gain expertise in ensuring cosmetic product safety through GMP compliance.

What does this ISO 22716 Lead Auditor Certification aim to achieve?

This certification aims to provide delegates with the skills and knowledge to lead ISO 22716 audits effectively, ensuring that cosmetic manufacturers comply with international GMP standards.

What is the difficulty level for the ISO 22716 Lead Auditor Course?

This course is considered moderately challenging, with delegates needing a good grasp of GMP and auditing principles. However, it is designed to be accessible to those with varying levels of experience.

What is the significance of holding this certification?

Holding the ISO 22716 Lead Auditor certification demonstrates your expertise in auditing cosmetic GMP practices, boosting your career opportunities and positioning you as a valuable asset to cosmetic manufacturers.

What is included in the ISO 22716 Lead Auditor Course?

The course includes comprehensive training on ISO 22716 guidelines, auditing techniques, case studies, group discussions, and a certification exam to assess your understanding and competency.

Which individuals or roles require this ISO 22716 Lead Auditor Online Training?

Quality Managers, Auditors, GMP Professionals, Regulatory Specialists, and anyone responsible for ensuring product safety in the cosmetics industry would benefit from this training.

What is the duration of this ISO 22716 Lead Auditor Course?

The duration of this ISO 22716 Lead Auditor Course is 5 days.

Do you provide corporate training for this ISO 22716 Lead Auditor?

Yes, The Knowledge Academy offers customised corporate training to meet the specific needs of organisations, ensuring teams are well-versed in ISO 22716 auditing and GMP.

Why should I take this ISO 22716 Lead Auditor Course Online?

Taking the course online offers flexibility and convenience, allowing you to learn at your own pace while gaining valuable auditing skills to advance your career in the cosmetics industry.

Do you offer 24/7 support for this ISO 22716 Lead Auditor Training Course?

Yes, The Knowledge Academy provides 24/7 support to ensure all delegates have access to assistance whenever they need it throughout their training journey.

What to do after this ISO 22716 Lead Auditor Online Training?

After completing the course, you can apply your skills in conducting audits, contribute to improving cosmetic manufacturing processes, and pursue further certifications in quality management.

Do you provide a self-paced course?

Yes, we offer a self-paced version of the ISO 22716 Lead Auditor Course, allowing you to complete the training at your convenience and progress at your own speed.

Who should I contact if I am unable to access this course online?

If you encounter any issues accessing the course, you can contact our support team, who are available 24/7 to assist with technical or course-related queries.

What kind of jobs can I expect based on this certification training course?

With this certification, you can pursue roles such as Lead Auditor, Quality Manager, Regulatory Affairs Specialist, or GMP Compliance Officer in the cosmetics and related industries.

Is there an examination for this ISO 22716 Lead Auditor Training Course?

Yes, the course concludes with an examination to assess your understanding of ISO 22716 guidelines and auditing practices. Passing the exam will earn you the Lead Auditor certification.

What is the cost/training fees for ISO 22716 Lead Auditor Training in Nepal?

The training fees for ISO 22716 Lead Auditor Training in Nepal starts from $3195

Which is the best training institute/provider of ISO 22716 Lead Auditor Training in Nepal?

The Knowledge Academy is one of the Leading global training provider for ISO 22716 Lead Auditor Training.

What are the best ISO Certification courses in Nepal?

Please see our ISO Certification courses available in Nepal

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