Course information

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

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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New Delhi is one of the districts within Delhi, as well as it being the capital city of India, it is also the home to the Government of the National Capital Territory of Delhi and some of the branches of the Government of India, these being the judiciary, executive and legislative branches and is also home to around 249,998 people. The capital of India - New Delhi was initiated within 1931 by Viceroy Lord Irwin however formed during 1911 by George V, who was the King of the United Kingdom as well as the Emperor of India and his British architects Sir Herbert Baker and Sir Edwin Lutyens formed the foundation stone and announced the capital city of India would be changed. The primary schools and secondary schools within New Delhi are either run privately or by the government and as of 2004 to 2005 there was around 1.5 million students going through the educational system within 2416 primary schools, 822,00 students in 715 middle schools and 669,000 students in 1576 secondary schools and around 500,000 students within 165 universities and colleges. All universities are either state, deemed or central universities, The top universities within New Delhi are the Jamia Millia Islamia, the University of Delhi, Indian Statistical Institute, National Law University, Jawaharlal Nehru University, Guru Gobind Singh Indraprastha University, Ambedkar University Delhi, Jamia Hamdard, Delhi Technological University – which is the first Engineering college within Delhi and one of the oldest in India, the Indira Gandhi National Open University is the largest national university in the world with over 4 million students, New Delhi is also home to the Indian Agricultural Research Institute, Pusa, New Delhi, Premier institute for agricultural research and education in India. The university courses and programs can offer different types of degrees such an undergraduate and post graduate courses, Bachelor courses and Scholarships, New Delhi prides itself on its premier institutions as the teaching and researching they do means that within 2011 the census recorded the literacy rate for females as 80.9% and for males it was slightly higher at 91.0% with an overall literacy rate of 86.3%. Subjects within the different universities can include, social sciences, engineering, humanities, technology, sports, law, social work, arts, management, education, computer information technology, foreign languages, mathematical science, dentistry and medical. 

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Address

Pioneer Institute of Education and Computer Studies
F322/A, 3rd Floor
Adarsh House (Above PNB Bank)
Old MB Road
Lado Sarai
New Delhi
110030

T: +91 8037244591

Ways to take this course

Experience live, interactive learning from home with The Knowledge Academy's Online Instructor-led ISO 22716 Lead Auditor Training | ISO Training in New Delhi. 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.

Unlock your potential with The Knowledge Academy's ISO 22716 Lead Auditor Training | ISO Training in New Delhi, accessible anytime, anywhere on any device. Enjoy 90 days of online course access, extendable upon request, and benefit from the support of our expert trainers. Elevate your skills at your own pace with our Online Self-paced sessions.

Experience the most sought-after learning style with The Knowledge Academy's ISO 22716 Lead Auditor Training | ISO Training in New Delhi. 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 | ISO Training in New Delhi sessions.

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"Really good course and well organised. Trainer was great with a sense of humour - his experience allowed a free flowing course, structured to help you gain as much information & relevant experience whilst helping prepare you for the exam"

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