Good Manufacturing Practices (GMP) Auditor Training

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Course Director

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Course Fee

$2150.00 Regular Registration

$1950.00 Early Bird Pricing (Register 30 Days in Advance)

GMP Auditor Training Course Description

This training provides a thorough review of the foundational principles from a regulatory statute/guidance perspective and discusses the best practical practices involved in conducting successful site audits.


It provides clear guidance on how to communicate and work with the site audit team to enable a successful site audit to be completed. The course will detail strategies to enable the auditing team to gain an accurate assessment of the state of compliance at the site.


The learning materials use a practice site inspection methodology with document reviews. 

Importance of Our Quality Systems Evaluation Course

The audit process is an important part of a modern Quality Management System, which provides the regulatory control mechanism to guarantee the quality of pharmaceutical and medical processes and products. It is a fundamental element of the Quality Management System, which enables both manufacturing sites and client companies to demonstrate and ensure compliance at a site. Accurate audits are essential for:

  • Product quality: The audit process helps ensure that the site is operating according to federal statutes and other global standards. GMP auditing provides a mechanism for the site to demonstrate it is operating within a quality culture and is under control. This helps ensure the quality of the products being manufactured and the safety of those products to the consumer.
  • Data integrity: Data Integrity is a serious issue that can lead to the disqualification of products, so this is featured as an important topic. This ensures that there is a clear appreciation of what is acceptable and what is unacceptable in terms of data and information management. Related to this topic, examples of investigational practices are discussed.
  • Effective communication: Underpinning all these issues is communication between the auditors and the internal audit team. This will be practiced in sessions that have been designed to involve role play exercises.



At the conclusion of the course, the attendee will be equipped to organize and conduct an audit that will generate sufficient information and data to be able to accurately determine the state of compliance of a site.

Who Is Our GMP Audit Report Writing Workshop For?

This 15-hour course provides an understanding of the responsibilities involved in conducting GMP Audits in the Pharmaceutical and Medical Device industries. This course is designed to be useful for those in the following positions:


  • Quality Assurance Professionals
  • Regulatory Affairs Specialists
  • Manufacturing Supervisors and Personnel
  • Auditors And Inspectors
  • Compliance Officers
  • Regulatory Agency Personnel and Inspectors
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  • Learning Objectives for Our Audit Training

    Learn what to expect from our GMP auditing training. 


    1. Regulatory Requirements and Guidelines

    This course covers the concepts and requirements of FDA 21 CFR 210 and 211 Pharmaceutical CGMP, ISO 13485 and ISO 19011 Lead Auditing, such as:

    • Auditing principles.
    • Managing audit programs.
    • Conducting audits.
    • Auditor competence.
    • Implementing auditing best practices.
    • Demonstrating credibility and capability in auditing internal systems.
    • Improving management systems and processes through structured audits.
    • Meeting customer and regulatory audit requirements.
    • Facilitating consistent auditor training and evaluation.

    2. Regulations for Manufacturing Compliance Inspections


    We stay current with the latest guidelines set by industry leaders, including the International Society for Pharmaceutical Engineering (ISPE), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the  U.S. Food and Drug Administration (USFDA). We share relevant information about: 

    • GMP regulations (e.g., FDA 21 CFR Parts 210/211, EMA EudraLex Volume 4), including their structure, legal status and practical application. 
    • Compliance during audits, (i.e., consistent auditor training and evaluation).

    3. ICH Guidelines


    The training focuses on documents like ICH Q10 (Pharmaceutical Quality System) and other relevant quality guidelines for the pharmaceutical industry.


    4. Data Integrity


    Our course covers the importance of data integrity and the ALCOA principles (Attributable, Legible, Contemporaneous, Original and Accurate) to ensure the reliability of pharmaceutical data.


    5. Auditing Principles and Methodology


    We provide educational information about:

    • ISO 19011:2018 guidelines: Training should cover the seven principles of auditing, which include confidentiality, due professional care, fair presentation, independence, integrity, risk-based approach and evidence-based approach.
    • Audit life cycle: Understanding the entire audit life cycle, including planning, preparation, performance, reporting and follow-up on corrective actions.
    • Types of audits: Distinguishing between internal, external, regulatory  and supplier audits and understanding their respective objectives.
    • Audit techniques: Developing skills in conducting effective document reviews, interviews  and on-site observations.
    • Generating audit findings: Identifying non-conformities, evaluating their significance  and classifying observations based on their potential impact.
    • Audit reporting: Structuring and writing comprehensive audit reports with clear and concise findings and recommendations.

    6. Auditor Skills and Competence

    Our course focuses on enhancing the following:

    • Communication skills: Developing effective communication skills for interviews, presenting findings  and interacting with auditees.
    • Interviewing techniques: Mastering techniques for conducting effective interviews with personnel at all levels.
    • Analytical skills: Developing strong analytical and problem-solving skills to interpret evidence and draw sound conclusions.
    • Objectivity and professionalism: Maintaining objectivity and professionalism throughout the audit process.

  • Agenda

    1. Regulatory requirements and guidelines

    Understanding of the concepts and requirements of FDA 21 CFR 210 and 211 Pharmaceutical CGMP, ISO 13485, and ISO 19011 Lead Auditing

    • Principles of Auditing
    • Managing Audit Programs
    • Conducting Audits
    • Auditor Competence
    • Implement auditing best practices.
    • Demonstrate credibility and capability in auditing internal systems.
    • Improve management systems and processes through structured audits.
    • Meet customer and regulatory audit requirements.
    • Facilitate consistent auditor training and evaluation.

    2. Good Manufacturing Practices (GMP) 

    • Detailed coverage of GMP regulations (e.g., FDA 21 CFR Parts 210/211, EMA EudraLex Volume 4), including their structure, legal status, and practical application. 
    • Auditors need to understand these regulations to assess compliance during audits, (i.e., consistent auditor training and evaluation)

    3. ICH Guidelines

    • Focusing on documents like ICH Q10 (Pharmaceutical Quality System) and other relevant quality guidelines for the pharmaceutical industry.

    4. Data Integrity

    • Emphasizing the importance of data integrity and the ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate) to ensure the reliability of pharmaceutical data.

    5. Auditing Principles and Methodology

    • ISO 19011:2018 Guidelines: Training should cover the seven principles of auditing: integrity, fair presentation, due professional care, confidentiality, independence, evidence-based approach, and risk-based approach.
    • Audit Lifecycle: Understanding the entire audit lifecycle, including planning, preparation, performance, reporting, and follow-up on corrective actions.
    • Types of Audits: Distinguishing between internal, external, regulatory, and supplier audits and understanding their respective objectives.
    • Audit Techniques: Developing skills in conducting effective document reviews, interviews, and on-site observations.
    • Generating Audit Findings: Identifying non-conformities, evaluating their significance, and classifying observations based on their potential impact.
    • Audit Reporting: Structuring and writing comprehensive audit reports with clear and concise findings and recommendations.

    6. Auditor Skills and Competence

    • Communication Skills: Developing effective communication skills for interviews, presenting findings, and interacting with auditees.
    • Interviewing Techniques: Mastering techniques for conducting effective interviews with personnel at all levels.
    • Analytical Skills: Developing strong analytical and problem-solving skills to interpret evidence and draw sound conclusions.
    • Objectivity and Professionalism: Maintaining objectivity and professionalism throughout the audit process.

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.