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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)

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Future Live Stream Sessions (click to register)

Course Description

The course provides a thorough review of the foundational principles from a regulatory statutes/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 course will set out a practical site inspection methodology to generate a logical flow that will generate a Lean approach to the process strategy including for document reviewing. Some common issues encountered will be shared.



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. The audit process helps to ensure that the site is operating according to federal statutes and other global standards. GMP auding 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 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.


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 Should Attend

This 15-hour course provides an understanding of the responsibilities involved in conducting GMP Audits in the Pharmaceutical and Medical Device industries.

 

This course will 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 & Inspectors
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  • Learning Objectives

    1. 1. Upon completion of the course, attendees will have a solid appreciation of the fundamentals of auditing in a regulatory environment, including the practical aspects of how to set up and implement a compliant audit process.
    2. 2. Attendees will be equipped with the practical strategy of how to conduct a site audit. This includes communications with the site, what you should expect from the site inspection team, what you can request in the audit process and how to handle interviewing site personnel.
    3. 3. How to provide feedback about the results of the audit including how to communicate any observations/findings that require remedial activities.
    4. 4. How to formally record audit findings in an inspection report.

    The course will use interactive sessions and discussions to enable delegates to exchange ideas and experiences while also learning from each other's experiences.


  • 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.