Regulatory Compliance Auditing for pharma manufacturers: 2-Day In-person Seminar

By: Joy McElroy, Principle Consultant at Maynard Consulting Company
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Course Description:

The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Compliance auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.

In this two day workshop conference you will learn the background and basics for regulatory compliance auditing.

Learning Objectives:

Upon completing this course participants should:

  • Understand what a regulatory compliance audit is.
  • Understand the background and basics of regulatory compliance auditing.
  • Understand proper Auditor conduct.
    • Communication
    • Dress
    • Punctuality
    • Difficult situations
  • Learn the necessary skills for conducting audits.
  • Understand how to prepare and plan for a regulatory compliance audit.
  • Understand and know how to properly perform an audit.
    • Opening meeting
    • Touring the facility
    • Questions
    • Observations
    • Close out meeting
  • Understand the types of regulatory compliance audits
  • Learn proper questioning techniques
  • Understand proper audit observation classification
  • Learn to write an audit report
  • Understand conducting a follow up audit
  • Learn how to become Lead Auditor certified
    • ASQ Certification
    • ISO Certification
    • Medical Device Certification

    Who will Benefit:

    This course is designed for people tasked with performing internal and external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation. The following personnel will benefit from the course:

    • Senior quality managers
    • Quality professionals
    • Regulatory professionals
    • Compliance professionals
    • Production supervisors
    • Validation engineers
    • Manufacturing engineers
    • Production engineers
    • Design engineers
    • Process owners
    • Quality engineers
    • Quality auditors
    • Document control specialists

    Course Outline

    Day One (8:30 AM – 4:30 PM)
    • 8:30 – 9:00 AM: Registration
    • 9:00 AM: Session Start Time
    1. Welcome, Introduction to the course and Speaker
    2. Regulatory Compliance Auditing
      1. Audit background and basics
      2. Definitions
      3. What is an Audit?
    3. Types of Regulatory Compliance Audits
      1. Internal Audits
      2. External Audits
        1. Supplier Audits
        2. Distributor Audits
        3. Due Diligence Audits
    4. Proper Auditor Conduct
      1. Communication
      2. Dress
      3. Punctuality
      4. Difficult Situations
    5. Skills for Conducting Regulatory Compliance Audits
      1. Responsibilities
      2. Knowledge
      3. Techniques
    6. Questions
    Day Two (8:30 AM – 4:30 PM)
    1. Preparing and Planning for a Regulatory Compliance Audit
    2. Performing the Audit
      1. Opening Meeting
      2. Touring the facility
      3. Questions
      4. Observations
      5. Close- Out Meeting
    3. Observation Classification
      1. Minor
      2. Major
      3. Critical
    4. Writing an Audit Report
      1. Time of delivery
      2. Cover letter
      3. Format of Report
    5. Conducting a Follow-up Audit
    6. Lead Auditor Certification Programs
      1. ASQ
      2. ISO
      3. Medical Device
    7. Questions

    Meet Your Instructor

    Joy-McElroy-90X112
    Joy McElroy
    Principle Consultant at Maynard Consulting Company

    Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.

    With over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize.

    Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.

    In 2013 Joy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.

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