Course Offerings

Litts Quality Technologies provides training courses throughout the year on various Management Systems and Employee Competency Enhancing topics. All programs are certified or approved. See full course descriptions below and look on the UPCOMING EVENTS/COURSES page to see active registrations.

AS9100 Rev. “D” Quality Management Systems—INTERNAL AUDITOR: 3-day course
ISO 9001:2015 Quality Management Systems—INTERNAL AUDITOR: 3-day course
ISO 9001:2015 Quality Management Systems—LEAD AUDITOR: 4-day course
ISO 13485:2016 Medical Devices—Quality Management Systems—INTERNAL AUDITOR: 3-day course
ISO 13485:2016 Medical Devices—Quality Management Systems—LEAD AUDITOR: 4-day course
ISO 15378-2017 Medicinal Packaging—INTERNAL AUDITOR: 3-day course
ISO 15378-2017 Medicinal Packaging—LEAD AUDITOR: 4-day course
ISO 17025:2017 Laboratory and Testing—INTERNAL ASSESSOR: 3-day course
ISO 17025:2017 Laboratory and Testing—LEAD ASSESSOR: 4-day course
ISO 14001:2015 Environmental—INTERNAL AUDITOR 3-day course
ISO 14001:2015 Environmental—LEAD AUDITOR: 4-day course
Geometric Dimensioning & Tolerancing: 2-day (minimum) course
Mechanical Drawing/Blueprint Reading: 1-day course

AS9100 Rev. “D” Quality Management Systems—Requirements for Aviation, Space and Defense Organizations Internal Auditor 20-Hour–PROBITAS Authentication Approved Course

This course is designed to be suitable by onsite, public venues or virtual delivery methods.

The AS9100 Rev. “D” and the ISO 19011:2018 Guidelines for Auditing Management Systems standards are the basis of this training. In addition, there will be a review of the:

- - Newly Released! AS9101 Rev. “G” Quality Management Systems Audit Requirements for Aviation, Space and Defense Organizations. This is the standard that defines the audit requirements for Certification Body (CB) auditors.
  - International Aerospace Quality Group (IAQG) organization, navigating the website and available forms, and
  - Online Aerospace Supplier Information System (IAQG-OASIS)

SESSION DATES

This is a 3-day course (20 hrs).

WHO SHOULD ATTEND

- - AS9100 Management Representatives
  - Quality Managers
  - Internal Auditors
  - Potential Internal Auditors
  - Auditors who want to start the process of becoming Third-Party Auditors
  - Supply Chain employees
  - Any management team member of an organization that is registered to or wants to become certified to AS9100 to gain an understanding of the requirements.

Please check UPCOMING EVENTS/COURSES page for schedules, email rick@littsquality.com, or call 1-877-LQT-6001 {1-877-578-6001}. If you have any questions regarding this information please feel free to contact us.

COURSE OBJECTIVE

The major objective of this course is to provide knowledge in the method of conducting internal audits of an AS9100 Rev. “D” Quality Management System (QMS) using the Process Approach auditing method. Attendees will also be able to apply their learned knowledge in leading improvement of their organization audit process and QMS.

The attendees will be able to function as internal (First Party) and interested party (Second Party) auditors. In addition, this will provide knowledge to begin the process of becoming a Certified Body (Third-party) auditor.

Exercises and quizzes are used to help with the understanding of the AS9100 Rev. “D” Quality Management Systems — Requirements for Aviation, Space and Defense Organizations Standard and Process Based Auditing Techniques and ISO 19011:2018 Guidelines for Auditing Management Systems

COURSE OUTLINE

DAY 1

- - Introductions
  - Course Objectives and Requirements
  - An overview of PROBITAS Authentication
  - The goals and objectives of the ISO 900X:20XX Family of Standards
  - Interaction of the ISO 900X:20XX QMS Standards with the AS9100 Rev. “D” Quality Management Systems — Requirements for Aviation, Space and Defense Organizations Standard
  - Concepts and language
  - Definitions
  - The 7 Quality Management Principles used in the development of the AS9100 Rev. “D” Quality Management Systems ~ Requirements for Aviation, Space and Defense Organizations Standard
  - Overview of AS9101 “G” Quality Management Systems Audit Requirements for Aviation, Space and Defense Organizations.
  - The International Aerospace Quality Group (IAQG) organization
  - Overview of the Online Aerospace Supplier Information System (IAQG-OASIS)
  - The detailed requirements of the AS9100 Rev. “D” Quality Management Systems — Requirements for Aviation, Space and Defense Organizations Standard

DAY 2

- - Quiz
  - Continuing review of the detailed requirements of the AS9100 Rev. “D” Quality Management Systems — Requirements for Aviation, Space and Defense Organizations Standard
  - The concepts of auditing using the Process Approach based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - The terms and definitions used in auditing
  - The Six Steps of Auditing Activities based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - International Aerospace Quality Group (IAQG) organization, navigating the website and available forms
  - How to use Process Effectiveness Audit Reports (PEARs)
  - Review of an Internal Audit Procedure

DAY 3

- - Quiz
  - Attendees review a case study and prepare to perform Mock Process Audits
  - Final Test (administered electronically)

COURSE MATERIALS

Litts Quality Technologies, Inc. will provide:

- - Student Workbooks
  - Certificates

PREREQUISITES

Attendees are required to obtain a copy of the AS9100 Rev. “D” QMS requirements standard and review prior to attending the course. This will help with navigating through the standard during the sessions. In addition, attendees need to bring the copy to the class.

It is also highly recommended, (but not necessary to attend the class) that the attendees obtain a copy of the ISO 19011:2018 Guidelines for Auditing Management Systems and having it available at the class.

COURSE REQUIREMENTS

A final test is administered the last day to evaluate the acquired knowledge and determine the effectiveness of the course program as required by management system standards.

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ISO 9001:2015 Quality Management Systems — Requirements Standard INTERNAL AUDITOR Exemplar Global Certified Course

This course is designed to be suitable by onsite, public venues or virtual delivery methods.

SESSION DATES

This is a 3-day course.

WHO SHOULD ATTEND

- - Management Representatives
  - Quality Managers
  - Internal Auditors
  - Potential Internal Auditors
  - Auditors who want to start the process of becoming Third-Party Auditors
  - Supply Chain employees
  - Any management team member of an organization that is registered to or wants to become registered to ISO 9001:2015 to gain an understanding of the requirements.

COURSE OBJECTIVE

The major objective of this course is to provide knowledge in the method of conducting internal audits of an ISO 9001:2015 Quality Management System (QMS) using the Process Approach auditing method. Attendees will also be able to apply their learned knowledge in leading improvement of their organization audit process and QMS.

The attendees will be able to function as internal (First Party) and interested party (Second Party) auditors. In addition, this will provide knowledge to become a Third-party auditor.

Exercises and quizzes are used to help with the understanding of the ISO 9001:2015 Quality Management Systems ~ Requirements Standard and Process Based Auditing Techniques.

Added benefit of taking this Certified Course:
Attendees will Receive from Exemplar Global

- - 12 months of ongoing professional development and support through direct access to a series of tailored learning content
  - Exemplar Global Graduate personnel certification to enhance their employment potential
  - Access to complete the Work Style Assessment self-coaching tool for professional growth
  - Access to an exclusive LinkedIn community to interact with other graduates and industry professionals to promote networking opportunities and skill sharing
  - Continuing professional development opportunities through access to webinars, online articles, and events
  - Greater support on their career path

COURSE OUTLINE

DAY 1

- - Introductions
  - Interaction of the ISO 900X:20XX QMS Standards
  - Course Objectives and Requirements
  - The goals and objectives of the ISO 900X:20XX Family of Standards
  - Concepts and language
  - Definitions
  - The 7 Quality Management Principles used in the development of the standard
  - The detailed requirements of the ISO 9001:2015 Quality Management Systems

DAY 2

- - Quiz
  - The concepts of auditing using the Process Approach based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - The terms and definitions used in auditing
  - The Six Steps of Auditing Activities based upon ISO 19011:2018 Guidelines for Auditing Management Systems- Step 1 – Initiating the Audit- Step 2 – Preparing Audit Activities- Step 3 – Conducting Audit Activities- Step 4 – Preparing, approving and distributing audit report- Step 5 – Completing Audit- Step 6 – Conducting audit follow-up
  - Review of an Internal Audit Procedure

DAY 3

- - Quiz
  - Attendees review a case study and prepare to perform Mock Process Audits
  - Final Test (administered electronically)
  - Course Evaluation

COURSE MATERIALS

Litts Quality Technologies, Inc. will provide a:

- - Student Workbooks (electronic, hardcopy, or a combination of both sent to you following registration)
  - Certificates

PREREQUISITES

Attendees are required to obtain a copy of the ISO 9001:2015 standard and review prior to attending the course. This will help with navigating through the standard during the sessions. In addition, attendees need to bring the copy to the class.

It is also highly recommended, (but not necessary to attend the class) that the attendees obtain a copy of the ISO 19011:2018 Guidelines for Auditing Management Systems and bring it to the class.

COURSE REQUIREMENTS

A final test is administered the last day to evaluate the acquired knowledge and determine the effectiveness of the course program as required by management system standards.

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ISO 9001:2015 Quality Management Systems — Requirement LEAD AUDITOR Exemplar Global Certified Course

This course is designed to be suitable by onsite, public venues or virtual delivery methods.

SESSION DATES

This is a 4-day course.

WHO SHOULD ATTEND

- - Quality Managers
  - Current Internal Auditors
  - Potential Internal Auditors
  - Auditors who want to start the process of becoming Third-Party Auditors
  - Purchasing employees
  - Any team member of an organization that is registered to or wants to become registered to ISO 9001:2015 to gain an understanding of the requirements

COURSE OBJECTIVE

The major objective of this course is to provide knowledge in the method of Leading Quality Management System (QMS) audits using the Process Approach auditing method. Attendees will also be able to apply their learned knowledge in leading improvement of their organization audit process.

The attendees will be able to function as Lead internal (First Party) or interested party (Second Party) auditors. In addition, this will provide knowledge to begin the process of becoming a Certified Body (Third-party) auditor.

Exercises and quizzes are used to help with the understanding of the ISO 9001:2015 Standard and Process Based Auditing Techniques.

Added benefit of taking this Certified Course:
Attendees will Receive from Exemplar Global

- - 12 months of ongoing professional development and support through direct access to a series of tailored learning content
  - Exemplar Global Graduate personnel certification to enhance their employment potential
  - Access to complete the Work Style Assessment self-coaching tool for professional growth
  - Access to an exclusive LinkedIn community to interact with other graduates and industry professionals to promote networking opportunities and skill sharing
  - Continuing professional development opportunities through access to webinars, online articles, and events
  - Greater support on their career path

COURSE OUTLINE

DAY 1

- - Introductions
  - Course Objectives and Requirements
  - An overview of Exemplar Global
  - An overview of the International Organization for Standardization (ISO) and available resources offered
  - The Strategic Direction and Context of an organization
  - The Concepts and Language used in the Standards
  - The goals and objectives of the ISO 9001:2015 Quality Management Systems – Requirements Standard, ISO 9000:2015 Quality Management Systems – Fundamentals and Vocabulary and ISO 9004:2018 Quality Management – Quality of an Organization – Guidance to achieve Sustained Success Family of Standards
  - Interaction of the ISO 900X:20XX QMS Standards
  - Concepts and language
  - Definitions
  - The 7 Quality Management Principles used in the development of the ISO 9001:2015 Standard
  - Begin the detailed review of ISO 9001:2015 Standard Clauses with exercises through-out

DAY 2

- - Quiz
  - Continuing review of the detailed requirements of the ISO 9001:2015 Standard Clauses
  - The concepts of auditing using the Process Approach based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - The terms and definitions used in auditing
  - The Six Steps of Auditing Activities based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - Review of an Audit Procedure and related forms

DAY 3

- - Quiz
  - Continuing review of The Six Steps of Auditing Activities based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - Attendees review a case study and prepare to perform Mock Process Audits
  - Review of an Audit Procedure and related forms

DAY 4

- - Quiz
  - Perform case study Mock Process Audits
  - Writing audit reports
  - Writing requests for corrective actions
  - How to follow-up and close out Corrective Actions
  - Complete the Exemplar Global Work Style Assessment self-coaching Tool
    (Note: Will need the ability to be able to access the Exemplar Global website – a link will be provided)
  - Final Test
  - Course Evaluation

COURSE MATERIALS

Litts Quality Technologies, Inc. will provide a:

- - Student Workbooks
  - Certificates

PREREQUISITES

It is also highly recommended, (but not necessary to attend the class) that the attendees obtain a copy of the ISO 19011:2018 Guidelines for Auditing Management Systems and bring it to the class.

COURSE REQUIREMENTS

A final test is administered the last day to evaluate the acquired knowledge and determine the effectiveness of the course program as required by management system standards.

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ISO 13485:2016 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes INTERNAL AUDITOR Exemplar Global Certified Course

This course is designed to be suitable by onsite, public venues or virtual delivery methods.

SESSION DATES

This is a 3-day course.

WHO SHOULD ATTEND

- - Quality Managers
  - Regulatory Managers
  - Current Internal Auditors
  - Potential Internal Auditors
  - Any team member of an organization that is registered to or wants to become registered to ISO 13485:2016 to gain an understanding of the requirements

COURSE OBJECTIVE

The major objective of this course is to provide knowledge in the method of conducting audits using the Process Approach auditing method. Attendees will also be able to apply their learned knowledge in leading improvement of their organization audit process.

The attendees will be able to function as Internal (First Party) or, interested party (Second Party) auditors.

Exercises and quizzes are used to help with the understanding of the ISO 13485:2016 Standard and Process Based Auditing Techniques.

Added benefit of taking this Certified Course:
Attendees will Receive from Exemplar Global

- - 12 months of ongoing professional development and support through direct access to a series of tailored learning content
  - Exemplar Global Graduate personnel certification to enhance their employment potential
  - Access to complete the Exemplar Global Work Style Assessment self-coaching tool for professional growth
  - Access to an exclusive LinkedIn community to interact with other graduates and industry professionals to promote networking opportunities and skill sharing
  - Continuing professional development opportunities through access to webinars, online articles, and events
  - Greater support on their career path

COURSE OUTLINE

DAY 1

- - Introductions
  - Course Objectives and Requirements
  - An overview of Exemplar Global
  - An overview of the International Organization for Standardization (ISO) and available resources offered
  - The Concepts and Language used in the Standards
  - Begin the detailed review of ISO 13485:2016 Standard Clauses with exercises through-out

DAY 2

- - Quiz
  - Continuing review of the detailed requirements of the ISO 13485:2016 Standard Clauses
  - The concepts of auditing using the Process Approach based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - The terms and definitions used in auditing

DAY 3

- - Quiz
  - Overview of GMP’s
  - Attendees review a case study and perform Mock Process Audits
  - How to follow-up and close out Corrective Actions
  - Complete the Exemplar Global Work Style Assessment self-coaching Tool
    (Note: Will need the ability to be able to access the Exemplar Global website – a link will be provided)
  - Final Test
  - Course Evaluation

COURSE MATERIALS

Litts Quality Technologies, Inc. will provide a:

- - Student Workbooks
  - Certificates

PREREQUISITES

Attendees are required to obtain a copy of the ISO 13485:2016 standard and review prior to attending the course. This will help with navigating through the standard during the sessions. In addition, attendees need to bring the copy to the class.

It is also highly recommended, (but not necessary to attend the class) that the attendees obtain a copy of the ISO 19011:2018 Guidelines for Auditing Management Systems and bring it to the class.

COURSE REQUIREMENTS

A final test is administered the last day to evaluate the acquired knowledge and determine the effectiveness of the course program as required by management system standards.

(back to top)

ISO 13485:2016 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes LEAD AUDITOR Exemplar Global Certified Course

This course is designed to be suitable by onsite, public venues or virtual delivery methods.

SESSION DATES

This is a 4-day course.

WHO SHOULD ATTEND

- - Quality Managers
  - Regulatory Managers
  - Current Internal Auditors
  - Potential Internal Auditors
  - Auditors who want to start the process of becoming Third-Party Auditors
  - Purchasing employees
  - Any team member of an organization that is registered to or wants to become registered to ISO 13485:2016 to gain an understanding of the requirements

COURSE OBJECTIVE

The attendees will be able to function as Lead Internal (First Party) or Interested party (Second Party) auditors. In addition, this will provide knowledge to begin the process of becoming a Certified Body (Third-party) auditor.

Exercises and quizzes are used to help with the understanding of the ISO 13485:2016 Standard and Process Based Auditing Techniques.

Added benefit of taking this Certified Course:
Attendees will Receive from Exemplar Global

- - 12 months of ongoing professional development and support through direct access to a series of tailored learning content
  - Exemplar Global Graduate personnel certification to enhance their employment potential
  - Access to complete the Exemplar Global Work Style Assessment self-coaching tool for professional growth
  - Access to an exclusive LinkedIn community to interact with other graduates and industry professionals to promote networking opportunities and skill sharing
  - Continuing professional development opportunities through access to webinars, online articles, and events
  - Greater support on their career path

COURSE OUTLINE

DAY 1

- - Introductions
  - Course Objectives and Requirements
  - An overview of Exemplar Global
  - An overview of the International Organization for Standardization (ISO) and available resources offered
  - The Strategic Direction and Context of an organization
  - The Concepts and Language used in the Standards
  - The goals and objectives of the ISO 13485:2016 Medical Device—Quality Management Systems—Requirements for Regulatory Purposes Standard, ISO 9000:2015 Quality Management Systems—Fundamentals and Vocabulary and ISO 9004:2018 Quality Management—Quality of an Organization—Guidance to achieve Sustained Success Family of Standards
  - Interaction of the ISO QMS Standards
  - Concepts and language
  - Definitions
  - Begin the detailed review of ISO 13485:2016 Standard Clauses with exercises through-out

DAY 2

- - Quiz
  - Continuing review of the detailed requirements of the ISO 13485:2016 Standard Clauses
  - The concepts of auditing using the Process Approach based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - The terms and definitions used in auditing
  - The Six Steps of Auditing Activities based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - Review of an Audit Procedure and related forms

DAY 3

- - Quiz
  - Continuing review of The Six Steps of Auditing Activities based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - GMP’s
  - Risk Management
  - Review of an Audit Procedure and related forms
  - Attendees begin review a case study and prepare to perform Mock Process Audits

DAY 4

- - Quiz
  - Perform case study Mock Process Audits
  - Writing audit reports
  - Writing requests for corrective actions
  - How to follow-up and close out Corrective Actions
  - Complete the Exemplar Global Work Style Assessment self-coaching Tool
    (Note: Will need the ability to be able to access the Exemplar Global website – a link will be provided)
  - Final Test
  - Course Evaluation

COURSE MATERIALS

Litts Quality Technologies, Inc. will provide a:

- - Student Workbooks
  - Certificates

PREREQUISITES

It is also highly recommended, (but not necessary to attend the class) that the attendees obtain a copy of the ISO 19011:2018 Guidelines for Auditing Management Systems and bring it to the class.

COURSE REQUIREMENTS

A final test is administered the last day to evaluate the acquired knowledge and determine the effectiveness of the course program as required by management system standards.

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ISO 15378:2017 Primary Packaging Materials for Medicinal Products—Particular Requirements for the Application of ISO 9001:2015, with Reference to Good Manufacturing Practice (GMP) INTERNAL AUDITOR Exemplar Global Certified Course

This course is designed to be suitable by onsite, public venues or virtual delivery methods.

SESSION DATES

This is a 3-day course.

WHO SHOULD ATTEND

- - Management Representatives
  - Quality Managers
  - Internal Auditors
  - Potential Internal Auditors
  - Any management team member of an organization that is registered to or wants to become registered to ISO 15378:2017 to gain an understanding of the requirement.

COURSE OBJECTIVE

The attendees will be able to function as Internal (First Party) or, interested party (Second Party) auditors.

The attendees will be able to function as Lead internal (First Party), or interested party (Second Party).

Exercises and quizzes are used to help with the understanding of the ISO 15378:2017 Primary Packaging Materials for Medicinal Products Standard and Process Based Auditing Techniques.

Added benefit of taking this Certified Course:
Attendees will Receive from Exemplar Global

- - 12 months of ongoing professional development and support through direct access to a series of tailored learning content
  - Exemplar Global Graduate personnel certification to enhance their employment potential
  - Access to complete the Work Style Assessment self-coaching tool
  - Access to an exclusive LinkedIn community to interact with other graduates and industry professionals to promote networking opportunities and skill sharing
  - Continuing professional development opportunities through access to webinars, online articles, and events
  - Greater support on their career path

COURSE OUTLINE

DAY 1

- - Introductions
  - Course Objectives and Requirements
  - An overview of Exemplar Global
  - The Strategic Direction and Context of an organization
  - The Concepts and Language used in the Standards
  - The goals and objectives of the ISO 9001:2015, ISO 9000:2015 and ISO 9004:2018 Family of Standards
  - Interaction of the ISO 900X:20XX QMS Standards with the ISO 15378:2017 Primary Packaging Materials for Medicinal Products
  - Detailed review of ISO 15378:2017 Primary Packaging Materials for Medicinal Products Standard

DAY 2

- - Quiz
  - Continuing review of the detailed requirements of the ISO 15378:2017 Primary Packaging Materials for Medicinal Products Standard
  - The concepts of auditing using the Process Approach based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - The terms and definitions used in auditing

DAY 3

- - Quiz
  - Review of GMP’s
  - Attendees review a case study and perform Mock Process Audits
  - How to follow-up and close out Corrective Actions
  - Complete the Exemplar Global Work Style Assessment self-coaching Tool
    (Note: Will need the ability to be able to access the Exemplar Global website – a link will be provided)
  - Final Test
  - Course Evaluation

COURSE MATERIALS

Litts Quality Technologies, Inc. will provide:

- - Student Workbooks
  - Certificates

PREREQUISITES

Attendees are required to obtain a copy of the ISO 15378:2017 Primary Packaging Materials for Medicinal Products standard and review prior to attending the course. This will help with navigating through the standard during the sessions. In addition, attendees need to bring the copy to the class.

It is also highly recommended, (but not necessary to attend the class) that the attendees obtain a copy of the ISO 19011:2018 Guidelines for Auditing Management Systems and bring it to the class.

For onsite or public held courses, LQT Inc. will have several loaner copies of the ISO 15378:2017 Primary Packaging Materials for Medicinal Products Standard available that may be shared with other attendees, during the course. These loaned copies cannot be marked-up during use.

COURSE REQUIREMENTS

A final test is administered the last day to evaluate the acquired knowledge and determine the effectiveness of the course program as required by management system standards.

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ISO 15378:2017 Primary Packaging Materials for Medicinal Products—Particular Requirements for the Application of ISO 9001:2015, with Reference to Good Manufacturing Practice (GMP) LEAD AUDITOR Exemplar Global Certified Course

This course is designed to be suitable by onsite, public venues or virtual delivery methods.

SESSION DATES

This is a 4-day course.

WHO SHOULD ATTEND

- - Management Representatives
  - Quality Managers
  - Internal Auditors
  - Potential Internal Auditors
  - Auditors who want to start the process of becoming Third-Party Auditors
  - Purchasing employees
  - Production employees
  - Any management team member of an organization that is registered to or wants to become registered to ISO 15378:2017 to gain an understanding of the requirement.

COURSE OBJECTIVE

Exercises and quizzes are used to help with the understanding of the ISO 15378:2017 Primary Packaging Materials for Medicinal Products Standard and Process Based Auditing Techniques.

Added benefit of taking this Certified Course:
Attendees will Receive from Exemplar Global

- - 12 months of ongoing professional development and support through direct access to a series of tailored learning content
  - Exemplar Global Graduate personnel certification to enhance their employment potential
  - Access to complete the Work Style Assessment self-coaching tool
  - Access to an exclusive LinkedIn community to interact with other graduates and industry professionals to promote networking opportunities and skill sharing
  - Continuing professional development opportunities through access to webinars, online articles, and events
  - Greater support on their career path

COURSE OUTLINE

DAY 1

- - Introductions
  - Course Objectives and Requirements
  - An overview of Exemplar Global
  - The Strategic Direction and Context of an organization
  - The Concepts and Language used in the Standards
  - The goals and objectives of the ISO 9001:2015, ISO 9000:2015 and ISO 9004:2018 Family of Standards
  - Interaction of the ISO 900X:20XX QMS Standards with the ISO 15378:2017 Primary Packaging Materials for Medicinal Products
  - Concepts and language
  - Definitions
  - The 7 Quality Management Principles used in the development of the ISO 15378:2017 Primary Packaging Materials for Medicinal Products Standard
  - Detailed review of ISO 15378:2017 Primary Packaging Materials for Medicinal Products Standard

DAY 2

- - Quiz
  - Continuing review of the detailed requirements of the ISO 15378:2017 Primary Packaging Materials for Medicinal Products Standard
  - The concepts of auditing using the Process Approach based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - The terms and definitions used in auditing
  - The Six Steps of Auditing Activities based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - Review of an Audit Procedure and related forms

DAY 3

- - Quiz
  - Continuing review of The Six steps of Auditing Activities based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - Review of GMP’s
  - Review of an Audit Procedure and related forms

DAY 4

- - Quiz
  - Perform case study Mock Process Audits
  - Writing audit reports
  - Writing requests for corrective actions
  - Complete the Exemplar Global Work Style Assessment self-coaching Tool
    (Note: Will need the ability to be able to access the Exemplar Global website – a link will be provided)
  - Final Test
  - Course Evaluation

COURSE MATERIALS

Litts Quality Technologies, Inc. will provide:

- - Student Workbooks
  - Certificates

PREREQUISITES

It is also highly recommended, (but not necessary to attend the class) that the attendees obtain a copy of the ISO 19011:2018 Guidelines for Auditing Management Systems and bring it to the class.

COURSE REQUIREMENTS

A final test is administered the last day to evaluate the acquired knowledge and determine the effectiveness of the course program as required by management system standards.

(back to top)

ISO 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories—INTERNAL ASSESSOR Exemplar Global Certified Course

This course is designed to be suitable by onsite, public venues or virtual delivery methods.

SESSION DATES

This is a 3-day course.

WHO SHOULD ATTEND:

- - Laboratory Managers
  - Testing Managers
  - Quality Managers
  - Current Internal Assessors
  - Potential Internal Assessors
  - Any team member of an organization that is accredited or wants to become accredited to ISO 17025:2017 to gain an understanding of the requirements

COURSE OBJECTIVE

The major objective of this course is to provide knowledge in the method of conducting assessment/audits using the Process Approach auditing method. Attendees will also be able to apply their learned knowledge in leading improvement of their organization audit process.

The attendees will be able to function as Internal (First Party) or, interested party (Second Party) assessors/auditors.

Exercises and quizzes are used to help with the understanding of the ISO 17025:2017 Standard and Process Based Assessing Techniques.

Added benefit of taking this Certified Course:
Attendees will Receive from Exemplar Global

- - 12 months of ongoing professional development and support through direct access to a series of tailored learning content
  - Exemplar Global Graduate personnel certification to enhance their employment potential
  - Access to complete the Work Style Assessment self-coaching tool for professional growth
  - Access to an exclusive LinkedIn community to interact with other graduates and industry professionals to promote networking opportunities and skill sharing
  - Continuing professional development opportunities through access to webinars, online articles, and events
  - Greater support on their career path

COURSE OUTLINE

DAY 1

- - Introductions
  - Course Objectives and Requirements
  - An overview of Exemplar Global
  - An overview of the International Organization for Standardization (ISO) and available resources offered
  - The Concepts and Language used in the Standards
  - The goals and objectives of the ISO 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories,
  - Use of either Option “A” or Option “B” in the development of an ISO 17025:2017 system
  - Begin the detailed review of ISO 17025:2017 Standard Clauses with exercises through-out

DAY 2

- - Quiz
  - Continuing review of the detailed requirements of the ISO 17025:2017 Standard Clauses
  - The concepts of assessing/auditing using the Process Approach based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - The terms and definitions used in auditing
  - Review of an Audit Procedure and related forms

DAY 3

- - Quiz
  - Measurement Uncertainty Overview
  - Attendees review a case study and prepare to perform Mock Process Audits
  - How to follow-up and close out Corrective Actions
  - Complete the Exemplar Global Work Style Assessment self-coaching Tool
    (Note: Will need the ability to be able to access the Exemplar Global website – a link will be provided)
  - Final Test
  - Course Evaluation

COURSE MATERIALS

Litts Quality Technologies, Inc. will provide a:

- - Student Workbooks
  - Certificates

PREREQUISITES

Attendees are required to obtain a copy of the ISO 17025:2017 standard and review prior to attending the course. This will help with navigating through the standard during the sessions. In addition, attendees need to bring the copy to the class.

It is also highly recommended, (but not necessary to attend the class) that the attendees obtain a copy of the ISO 19011:2018 Guidelines for Auditing Management Systems and bring it to the class.

COURSE REQUIREMENTS

A final test is administered the last day to evaluate the acquired knowledge and determine the effectiveness of the course program as required by management system standards.

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ISO 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories—LEAD ASSESSOR Exemplar Global Certified Course

This course is designed to be suitable by onsite, public venues or virtual delivery methods.

SESSION DATES

This is a 4-day course.

WHO SHOULD ATTEND:

- - Laboratory Managers
  - Testing Managers
  - Quality Managers
  - Current Internal Assessors
  - Potential Internal Assessors
  - Auditors who want to start the process of becoming Third-Party Assessors
  - Purchasing employees
  - Organization Source Inspectors
  - Government Source Inspectors
  - Any team member of an organization that is accredited or wants to become accredited to ISO 17025:2017 to gain an understanding of the requirements

COURSE OBJECTIVE

The major objective of this course is to provide knowledge in the method of Leading Quality Management System (QMS) assessments/audits using the Process Approach auditing method. Attendees will also be able to apply their learned knowledge in leading improvement of their organization audit process.

The attendees will be able to function as Lead Internal (First Party) or interested party (Second Party) assessors/auditors. In addition, this will provide knowledge to begin the process of becoming an Accreditation Body (Third-party) auditor.

Exercises and quizzes are used to help with the understanding of the ISO 17025:2017 Standard and Process Based Assessing Techniques.

Added benefit of taking this Certified Course:
Attendees will Receive from Exemplar Global

- - 12 months of ongoing professional development and support through direct access to a series of tailored learning content
  - Exemplar Global Graduate personnel certification to enhance their employment potential
  - Access to complete the Work Style Assessment self-coaching tool for professional growth
  - Access to an exclusive LinkedIn community to interact with other graduates and industry professionals to promote networking opportunities and skill sharing
  - Continuing professional development opportunities through access to webinars, online articles, and events
  - Greater support on their career path

COURSE OUTLINE

DAY 1

- - Introductions
  - Course Objectives and Requirements
  - An overview of Exemplar Global
  - An overview of the International Organization for Standardization (ISO) and available resources offered
  - An overview of the ISO Committee on Conformity Assessment (CASCO)
  - The Strategic Direction and Context of an organization
  - The Concepts and Language used in the Standards
  - The goals and objectives of the ISO 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories, ISO 9000:2015 Quality Management Systems – Fundamentals and Vocabulary and ISO 9004:2018 Quality Management – Quality of an Organization – Guidance to achieve Sustained Success Family of Standards
  - Interaction of the ISO 900X:20XX QMS Standards
  - Use of Option “A” or Option “B” in the development of a QMS for an ISO 17025:2017 system
  - Concepts and language
  - Definitions
  - The 7 Quality Management Principles used in the development of the ISO 9001:2015 Standard
  - Begin the detailed review of ISO 17025:2017 Standard Clauses with exercises through-out

DAY 2

- - Quiz
  - Continuing review of the detailed requirements of the ISO 17025:2017 Standard Clauses
  - The concepts of assessing/auditing using the Process Approach based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - The terms and definitions used in auditing
  - The Six Steps of Auditing Activities based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - Review of an Audit Procedure and related forms

DAY 3

- - Quiz
  - Continuing review of The Six Steps of Auditing Activities based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - Measurement Uncertainty Overview
  - Attendees review a case study and prepare to perform Mock Process Audits

DAY 4

- - Quiz
  - Perform case study Mock Process Audits
  - Writing audit reports
  - Writing requests for corrective actions
  - How to follow-up and close out Corrective Actions
  - Complete the Exemplar Global Work Style Assessment self-coaching Tool
    (Note: Will need the ability to be able to access the Exemplar Global website – a link will be provided)
  - Final Test
  - Course Evaluation

COURSE MATERIALS

Litts Quality Technologies, Inc. will provide a:

- - Student Workbooks
  - Certificates

PREREQUISITES

It is also highly recommended, (but not necessary to attend the class) that the attendees obtain a copy of the ISO 19011:2018 Guidelines for Auditing Management Systems and bring it to the class.

COURSE REQUIREMENTS

A final test is administered the last day to evaluate the acquired knowledge and determine the effectiveness of the course program as required by management system standards.

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ISO 14001:2015 Environmental Management Systems—Requirements with Guidance for Use INTERNAL AUDITOR Exemplar Global Certified Course

This course is designed to be suitable by onsite, public venues or virtual delivery methods.

SESSION DATES

This is a 3-day course.

WHO SHOULD ATTEND:

- - Environmental Managers
  - Regulatory Affairs Managers
  - Quality Managers
  - Current Internal Auditors
  - Potential Internal Auditors
  - Purchasing employees
  - Any team member of an organization that is registered to or wants to become registered to ISO 14001:2015 to gain an understanding of the requirements

COURSE OBJECTIVE

The attendees will be able to function as Internal (First Party) or, interested party (Second Party) auditors.

Added benefit of taking this Certified Course:
Attendees will Receive from Exemplar Global

- - 12 months of ongoing professional development and support through direct access to a series of tailored learning content
  - Exemplar Global Graduate personnel certification to enhance their employment potential
  - Access to complete the Work Style Assessment self-coaching tool for professional growth
  - Access to an exclusive LinkedIn community to interact with other graduates and industry professionals to promote networking opportunities and skill sharing
  - Continuing professional development opportunities through access to webinars, online articles, and events
  - Greater support on their career path

COURSE OUTLINE

DAY 1

- - Introductions
  - Course Objectives and Requirements
  - An overview of Exemplar Global
  - An overview of the International Organization for Standardization (ISO) and available resources offered
  - The Strategic Direction and Context of an organization
  - The Concepts and Language used in the Standards
  - Begin the detailed review of ISO 14001:2015 Standard Clauses with exercises through-out

DAY 2

- - Quiz
  - Continuing review of the detailed requirements of the ISO 14001:2015 Standard Clauses
  - The concepts of auditing using the Process Approach based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - The terms and definitions used in auditing
  - Review of an Audit Procedure and related forms

DAY 3

- - Quiz
  - Attendees review a case study and prepare to perform Mock Process Audits
  - How to follow-up and close out Corrective Actions
  - Course Review
  - Complete the Exemplar Global Work Style Assessment self-coaching Tool
    (Note: Will need the ability to be able to access the Exemplar Global website – a link will be provided)
  - Final Test
  - Course Evaluation

COURSE MATERIALS

Litts Quality Technologies, Inc. will provide a:

- - Student Workbooks
  - Certificates

PREREQUISITES

Attendees are required to obtain a copy of the ISO 14001:2015 standard and review prior to attending the course. This will help with navigating through the standard during the sessions. In addition, attendees need to bring the copy to the class.

It is also highly recommended, (but not necessary to attend the class) that the attendees obtain a copy of the ISO 19011:2018 Guidelines for Auditing Management Systems and bring it to the class.

COURSE REQUIREMENTS

A final test is administered the last day to evaluate the acquired knowledge and determine the effectiveness of the course program as required by management system standards.

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ISO 14001:2015 Environmental Management Systems—Requirements with Guidance for Use LEAD AUDITOR Exemplar Global Certified Course

This course is designed to be suitable by onsite, public venues or virtual delivery methods.

SESSION DATES

This is a 4-day course.

WHO SHOULD ATTEND:

- - Environmental Managers
  - Quality Managers
  - Current Internal Auditors
  - Potential Internal Auditors
  - Auditors who want to start the process of becoming Third-Party Auditors
  - Purchasing employees
  - Any team member of an organization that is registered to or wants to become registered to ISO 14001:2015 to gain an understanding of the requirements

COURSE OBJECTIVE

The major objective of this course is to provide knowledge in the method of Leading Environmental Management System (EMS) audits using the Process Approach auditing method. Attendees will also be able to apply their learned knowledge in leading improvement of their organization audit process

The attendees will be able to function as Lead internal (First Party), Interested party (Second Party) and Certification Body (Third Party) auditors.

Exercises and quizzes are used to help with the understanding of the ISO 14001:2015 Standard and Process Based Auditing Techniques.

Added benefit of taking this Certified Course:
Attendees will Receive from Exemplar Global

- - 12 months of ongoing professional development and support through direct access to a series of tailored learning content
  - Exemplar Global Graduate personnel certification to enhance their employment potential
  - Access to complete the Work Style Assessment self-coaching tool for professional growth
  - Access to an exclusive LinkedIn community to interact with other graduates and industry professionals to promote networking opportunities and skill sharing
  - Continuing professional development opportunities through access to webinars, online articles, and events
  - Greater support on their career path

COURSE OUTLINE

DAY 1

- - Introductions
  - Course Objectives and Requirements
  - An overview of Exemplar Global
  - An overview of the International Organization for Standardization (ISO) and available resources offered
  - The Strategic Direction and Context of an organization
  - The Concepts and Language used in the Standards
  - The goals and objectives of the ISO 14001:2015 Environmental Management Systems – Requirements with Guidance for Use
  - Overview of ISO 9000:2015 Quality Management Systems – Fundamentals and Vocabulary and ISO 9004:2018 Quality Management – Quality of an Organization – Guidance to achieve Sustained Success
  - Concepts and language
  - Definitions
  - Begin the detailed review of ISO 14001:2015 Standard Clauses with exercises through-out

DAY 2

- - Quiz
  - Continuing review of the detailed requirements of the ISO 14001:2015 Standard Clauses
  - The concepts of auditing using the Process Approach based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - The terms and definitions used in auditing
  - The Six Steps of Auditing Activities based upon ISO 19011:2018 Guidelines for Auditing Management Systems
    – Step 1 – Initiating the Audit
    – Step 2 – Preparing Audit Activities
    – Step 3 – Conducting Audit Activities
    – Step 4 – Preparing, approving and distributing audit report
    – Step 5 – Completing Audit
    – Step 6 – Conducting audit follow-up
  - Review of an Audit Procedure and related forms

DAY 3

- - Quiz
  - Continuing review of The Six Steps of Auditing Activities based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  - Attendees review a case study and prepare to perform Mock Process Audits
  - Writing audit reports
  - Writing requests for corrective actions
  - How to follow-up and close out Corrective Actions

DAY 4

- - Course Review
  - Complete the Exemplar Global Work Style Assessment self-coaching Tool
    (Note: Will need the ability to be able to access the Exemplar Global website – a link will be provided)
  - Final Test
  - Course Evaluation

COURSE MATERIALS

Litts Quality Technologies, Inc. will provide a:

- - Student Workbooks
  - Certificates

PREREQUISITES

It is also highly recommended, (but not necessary to attend the class) that the attendees obtain a copy of the ISO 19011:2018 Guidelines for Auditing Management Systems and bring it to the class.

COURSE REQUIREMENTS

A final test is administered the last day to evaluate the acquired knowledge and determine the effectiveness of the course program as required by management system standards.

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Geometric Dimensioning & Tolerancing course. The ASME Y14.5-2018 Dimensioning and Tolerancing standard is the basis of this training. This is an Exemplar Global Certified Course.

This course is designed to be suitable by onsite or at public venues .

SESSION DATES

This is a 2-day (minimum) course.

WHO SHOULD ATTEND

This training course is suited for employees who have some knowledge of GD&T or are interested in gaining their initial experience in this subject.

COURSE OBJECTIVE

The ASME Dimensioning and Tolerancing Standard Y14.5-2018 is the next revision of the 2009 standard. The majority of organizations are still using the previous revisions of the standard. In many instances, organizations have not updated their drawings and continue to reference even much earlier revisions of the standard, which are obsolete.

The major objective of this course is to provide the attendees with the knowledge of the basic concepts of GD&T so that they can lead the organization in meeting customer and internal product requirements.

This GD&T Training will provide attendees the skills necessary to understand the basic concepts of this subject.

Class exercises are used to help with the understanding of the ASME Standard requirements. Attendees are encouraged to bring drawings and parts (if they exist) to public and on-site training sessions for discussion purposes.

At the conclusion of the GD&T training program participants will be able to:

- - Define GD&T and explain how it is different from the conventional coordinate system of dimensioning and tolerancing.
  - Explain the benefits of GD&T.
  - Explain & Interpret each of the Geometric Characteristics
  - Explain the purpose of datums and how to identify them.
  - Explain the difference between clearance, interference and transition fits.
  - Explain the format of a feature control frame.
  - Determine if a bonus tolerance is applicable and calculate the resulting geometric tolerance.
  - Determine how each geometric tolerance is verified.
  - Apply the skills learned.
  - Read and interpret drawings and blueprints that specify GD&T.
  - Model-based applications
  - Use the ASME Y14.5-2018 Dimensioning and Tolerancing Standards as reference.

COURSE OUTLINE

- - Basic Principles
  - Definitions and benefits of GD&T
  - Basic Terminology
  - Tolerance
  - Geometric Characteristic
  - Geometric Tolerance
  - Datums
  - Basic Dimensions
  - Maximum Material Condition & Boundary Condition
  - Minimum Material Condition & Boundary Condition
  - Clearance, interference and Transition fits
  - Interpreting GD&T Symbols
  - Format of feature control frame
  - The Geometric Characteristics
  - Diameter symbol and the associated tolerance
  - Coordinate vs. position system tolerance zones
  - Effect of material condition on size
  - Regardless of feature size
  - Tolerances of Form
  - Tolerances of Orientation
  - Tolerances of Position
  - Tolerances of Profile
  - Tolerances of Runout
  - Inspection techniques

COURSE MATERIALS

Litts Quality Technologies, Inc. will provide a:

- - Student Workbook
  - Pocket Guide

PREREQUISITES

There is a pre-assessment given at the beginning of the course. This will establish a baseline of knowledge for each attendee. For training held at company sites, this may be given prior to the first day of the course.

COURSE REQUIREMENTS

A final test is administered the last day to evaluate the acquired knowledge and determine the effectiveness of the course program as required by management system standards.

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Mechanical Drawing/Blueprint Reading Exemplar Global Certified Course

This course is designed to be suitable by onsite, public venues or virtual delivery methods.

SESSION DATES

This is a 1-day course.

WHO SHOULD ATTEND

- - Quality Managers
  - Quality Engineers
  - Quality Department employees
  - Recently graduated Engineers
  - Designers
  - Inspectors
  - Machine or Coordinate Measuring Machine Programmers
  - Machinists
  - Assemblers
  - Current Internal Auditors
  - Potential Internal Auditors
  - Purchasing employees
  - Sales/Marketing employees
  - Any team member of an organization that wants to gain an understanding of this topic.

COURSE OBJECTIVE

The major objective of this course is to improve the attendee’s ability to read and understand the content of drawings/blueprints that they use to produce customer product. While Solid Modeling is widely in use today, there is still a need to read, interpret and understand mechanical drawings/ blueprints as they are common in manufacturing environments.

Attendees will be able to describe the layout of a drawing, interpret the various types of lines shown, determine when and how to apply the general tolerances specified in the title box and use the drawing to determine component dimensional requirements. In addition, they will be able to look at the body of the drawing and determine which views of the part are shown and how to assemble individual components. This will improve the attendee’s ability to correctly machine, assemble, program and/or inspect product.

This course has been revised to include Solid Modeling concepts.

Class exercises are used to help with the understanding of the requirements that designers put on Mechanical Drawings/Blueprints. Attendees are encouraged to bring drawings that they use to the class for their own reference in doing exercises.

COURSE OUTLINE

- - Introductions
  - Course Objectives and Requirements
    - Definitions and benefits of Mechanical Drawings/Blueprints
    - Basic Terminology
    - Title box
    - Revision controls
    - Bill of Material (BOM)
    - Specifications
    - Fundamental Rules
    - Units of measure
    - Scaling
    - General tolerancing and related principles
    - Tolerances and Tolerance expression
    - Views & Sections
    - Datums
    - Basic Dimensions
    - Types of Dimension Lines
    - Chain, baseline and direct dimensioning
    - Limit dimensioning and plus/minus tolerancing
    - Inch/metric systems
    - Fractions & decimals
    - GD&T Symbols – (not a detailed overview. Attendees are encouraged to attend the ASME Y14.5 Dimensional and Tolerancing – GD&T Course for improving their knowledge)
    - Surface Texture Symbols
    - Welding Symbols
    - 3D modeling
  - Final Test
  - Course Evaluation

COURSE MATERIALS

Litts Quality Technologies, Inc. will provide:

- - Student Workbooks
  - Certificates

PREREQUISITES

COURSE REQUIREMENTS

A final test is administered the last day to evaluate the acquired knowledge and determine the effectiveness of the course program as required by management system standards.

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Litts Quality Technologies provides training courses throughout the year on various Management Systems and Employee Competency Enhancing topics. All programs are certified or approved. See full course descriptions below and look on the UPCOMING EVENTS/COURSES page to see active registrations.

AS9100 Rev. “D” Quality Management Systems—INTERNAL AUDITOR: 3-day course

ISO 9001:2015 Quality Management Systems—INTERNAL AUDITOR: 3-day course

ISO 9001:2015 Quality Management Systems—LEAD AUDITOR: 4-day course

ISO 13485:2016 Medical Devices—Quality Management Systems—INTERNAL AUDITOR: 3-day course

ISO 13485:2016 Medical Devices—Quality Management Systems—LEAD AUDITOR: 4-day course

ISO 15378-2017 Medicinal Packaging—INTERNAL AUDITOR: 3-day course

ISO 15378-2017 Medicinal Packaging—LEAD AUDITOR: 4-day course

ISO 17025:2017 Laboratory and Testing—INTERNAL ASSESSOR: 3-day course

ISO 17025:2017 Laboratory and Testing—LEAD ASSESSOR: 4-day course

ISO 14001:2015 Environmental—INTERNAL AUDITOR 3-day course

ISO 14001:2015 Environmental—LEAD AUDITOR: 4-day course

Geometric Dimensioning & Tolerancing: 2-day (minimum) course

Mechanical Drawing/Blueprint Reading: 1-day course

AS9100 Rev. “D” Quality Management Systems—Requirements for Aviation, Space and Defense Organizations Internal Auditor 20-Hour–PROBITAS Authentication Approved Course

SESSION DATES

WHO SHOULD ATTEND

COURSE OBJECTIVE

COURSE OUTLINE

COURSE MATERIALS

PREREQUISITES

COURSE REQUIREMENTS

ISO 9001:2015 Quality Management Systems — Requirements Standard INTERNAL AUDITOR Exemplar Global Certified Course

SESSION DATES

WHO SHOULD ATTEND

COURSE OBJECTIVE

COURSE OUTLINE

COURSE MATERIALS

PREREQUISITES

COURSE REQUIREMENTS

ISO 9001:2015 Quality Management Systems — Requirement LEAD AUDITOR Exemplar Global Certified Course

SESSION DATES

WHO SHOULD ATTEND

COURSE OBJECTIVE

COURSE OUTLINE

COURSE MATERIALS

PREREQUISITES

It is also highly recommended, (but not necessary to attend the class) that the attendees obtain a copy of the ISO 19011:2018 Guidelines for Auditing Management Systems and bring it to the class.

COURSE REQUIREMENTS

ISO 13485:2016 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes INTERNAL AUDITOR Exemplar Global Certified Course

SESSION DATES

WHO SHOULD ATTEND

COURSE OBJECTIVE

COURSE OUTLINE

COURSE MATERIALS

PREREQUISITES

COURSE REQUIREMENTS

ISO 13485:2016 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes LEAD AUDITOR Exemplar Global Certified Course

SESSION DATES

WHO SHOULD ATTEND

COURSE OBJECTIVE

COURSE OUTLINE

COURSE MATERIALS

PREREQUISITES

COURSE REQUIREMENTS

ISO 15378:2017 Primary Packaging Materials for Medicinal Products—Particular Requirements for the Application of ISO 9001:2015, with Reference to Good Manufacturing Practice (GMP) INTERNAL AUDITOR Exemplar Global Certified Course

SESSION DATES

WHO SHOULD ATTEND

COURSE OBJECTIVE

COURSE OUTLINE

COURSE MATERIALS

PREREQUISITES

COURSE REQUIREMENTS

ISO 15378:2017 Primary Packaging Materials for Medicinal Products—Particular Requirements for the Application of ISO 9001:2015, with Reference to Good Manufacturing Practice (GMP) LEAD AUDITOR Exemplar Global Certified Course

SESSION DATES

WHO SHOULD ATTEND

COURSE OBJECTIVE

COURSE OUTLINE

COURSE MATERIALS

PREREQUISITES

COURSE REQUIREMENTS

ISO 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories—INTERNAL ASSESSOR Exemplar Global Certified Course

SESSION DATES

WHO SHOULD ATTEND:

COURSE OBJECTIVE

COURSE OUTLINE

COURSE MATERIALS

PREREQUISITES

COURSE REQUIREMENTS