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  

Why choose us

Our Omaha venue

Includes..

Free Wi-Fi

To make sure you’re always connected we offer completely free and easy to access wi-fi.

Air conditioned

To keep you comfortable during your course we offer a fully air conditioned environment.

Full IT support

IT support is on hand to sort out any unforseen issues that may arise.

Video equipment

This location has full video conferencing equipment.

Omaha is the county seat of Douglas County, located on the Missouri River in Nebraska it is the largest city within the state. Omaha is home to an estimated 446,599 people within 2014 therefore making it the 41st biggest city within the United States. The metropolitan population for Omaha is estimated at around 895,151 people. Omaha has a relatively low unemployment rate of 02.90% which has been decreased over the year by 0.5% from the year before when the unemployment rate was 03.40% whilst the average rate for Nebraska cities is also 2.90%. Omaha a number of different schools for students to attend which are public and overlooked by the Omaha Public School District and includes over 80 schools, some of these include Druid Hill Elementary School, Harrison Elementary School and the Springville Elementary School as well as Omaha Central High School, Omaha South High School and the Omaha Burke High School. There is also Catholic schools operated by the Roman Catholic Archdiocese of Omaha for students to enrol in as well as Private schools, some of which include the Omaha Christian Academy, Montessori Children's House and the Phoenix Academy of Learning. Omaha is also home to a number of colleges and universities, some of which are the Eppley Cancer Centre, the University of Nebraska Omaha, Creighton University and the University of Nebraska Medical Centre all of which offer different types of degrees such as associates, bachelors and masters and all in a variety of subjects. 

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Address

Linden Place
14301 First National Bank Parkway
Suite 100
Omaha
Nebraska
68154

T: +1 7204454674

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 Omaha. 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 Omaha, 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.

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

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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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