Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies

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    "The Course Director brought a new perspective to training which I have received (repeatedly) over my 26 years in the small molecule pharma industry – the discussion was fresh! The most interesting GLP training I have attended in years."


    Susan L., Quality Control Scientist, Incyte

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    "We have had extensive training in the webinar setting, but this was much more comprehensive as a course setting. The information was presented in a very clear and detailed manner, in line with other information we have pulled in from consultants."


    Dr. Jaime L., Associate Manager, Regulatory Services, GENEWIZ

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    "I really enjoyed the class. It was easy to interact and ask questions. The materials (binder, etc.) provided are great! They will be a wonderful reference for our lab."


    Melissa R., Research Asst. III, Wyss Institute

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    "The course director made the course very informative with real life anecdotes. This was a great class!"  


    Deepa D., Lab Operations Specialist, Canon US Life Sciences

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Course Director

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Course Fee

$2650.00 Regular Registration

$2450.00 Early Bird Pricing (Register 30 Days in Advance)

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Course Description

Good laboratory practices (GLP) for nonclinical laboratory studies are guidelines that ensure professionals conduct their research consistently, safely and reliably. CfPIE GLP nonclinical laboratory studies training provides participants with a comprehensive understanding of the terminology, regulations and mandated practices for conducting a study in compliance with GLP regulations.



Those attending will receive a thorough briefing on the importance of accurate documentation, instrument calibration and maintenance and the validation of relevant methodologies.

What This Course Covers

Specifically, this course covers:

Leadership Responsibilities

This course covers the roles and responsibilities of test site management and the study director, including planning, supervising and managing nonclinical studies. You will examine critical operational requirements, including:

  • Personnel and documentation: You will learn the requirements for training staff, good documentation practices, study protocols, reports and standard operating procedures (SOPs).
  • Equipment validation: The course discusses the requirements for equipment, such as qualification, installation, operation, performance and maintenance.
  • Facility standards: We'll cover the special GLP requirements for testing facilities, including the archives.
  • Study conduct: The course also discusses GLP regulation requirements for nonclinical studies regarding animal welfare, data integrity and thorough chain-of-custody for specimens and materials.


Quality Assurance Protocols

Our nonclinical laboratory compliance training includes a discussion of the functions of the quality assurance unit (QAU). It also discusses the need to effectively audit laboratory activities and data for compliance with GLP regulations and internal SOPs and test methods. Successful audits result from good planning and effective communication between quality assurance (QA) staff and management.

This course will cover a range of audit activities that you must conduct to assure management that laboratory studies are performed in compliance with the regulatory standards stated in the study protocol.

Regulatory Inspections

This course covers the responsibilities of QA in monitoring laboratory activities during data collection, analysis and the archiving of study information. We'll also present the roles of the study director and QA in regulatory and client inspections. Additionally, our GLP testing facility training will show you how to manage regulatory agency inspections and respond to noncompliance findings identified during them. Inspection results for sponsor companies and contract research organizations (CROs) are included in these discussions.

Who Should Attend GLP Training?

GLP generally refers to a quality system of management controls for laboratories and research organizations. It regulates the entire life cycle of nonclinical safety studies, from initial planning and execution to monitoring, documentation, reporting and final archiving.


Many bioanalytical laboratories also chose to follow GLP as the quality system for the testing of specimens from pharmacokinetic and other clinical studies. This ensures the consistency and reliability of results for submissions to the U.S. Food and Drug Administration (FDA), the Environmental Protection Agency (EPA) and other federal agencies.


Professional Roles

This 20-hour GLP training course is suitable for people who actively participate in regulated laboratory studies, including:

  • Managerial and laboratory scientists
  • Regulatory affairs personnel
  • Compliance personnel
  • Principal investigators
  • Study directors
  • Study monitors
  • QA and quality control managers
  • Multisite project coordinators
  • Auditors
  • Senior management
  • Professionals working at CROs

This course can also benefit professionals whose job function necessitates the generation, evaluation, assurance and submission of laboratory data to Organization for Economic Co-operation and Development (OECD) member countries and other national regulatory agencies.

Applicable Industries

Professionals working in the following industries will learn the fundamental principles and applications of GLP, particularly in complex multisite environments:

  • Food
  • Pharmaceutical
  • Medical device
  • Nutraceutical
  • Agrochemical
  • Cosmetics



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Additional Course Information

  • Learning Objectives

    By the end of this three-day course, attendees will have a strong understanding of the fundamental GLP compliance requirements. While the focus of this course is the U.S. FDA GLP regulation, Title 21, Code of Federal Regulations Part 58, other standards, such as the U.S. EPA GLPs, OECD GLP principles, and other international regulations, will also be presented for comparison.


    All participants will gain a fundamental understanding of the basis of the regulations and the necessity of rigorous implementation. Special attention will be given to incorporating proactive thinking and a robust compliance regimen in all scientific matters. The consequences of noncompliance will be examined, including a thorough review of examples of past FDA inspectional findings.

  • Agenda

    Section 1: Introduction: The GLPs

    • Historical perspective and development
    • Role and philosophy of the FDA
    • Role of other federal agencies
    • FDA regulations/guidelines/policies
    • International GLP, ISO and harmonization
    • When you need GLP and when you don't

    Section 2: The Regulations: 21 CFR 58


    • Subpart A: General Provisions
    • Subpart B: Organization and Personnel
    • Subpart C: Facilities
    • Subpart D: Equipment
    • Subpart E: Testing Facility Operations
    • Subpart F: Test and Control Articles
    • Subpart G: Protocol and Conduct of a Nonclinical Laboratory Study
    • Subpart J: Records and Reports
    • Subpart K: Disqualification

    Section 3: It Starts at the Top: Organization, Management and Documentation


    • Organization and management structure: Roles and responsibilities of the test facility management, study director, and QAU, regulatory implications, involvement of personnel from a wide variety of functions, and multisite studies.
    • Requirements for staff training and documentation: Certification for employees, job competency standards, job descriptions, continuing education programs and periodic refreshers, and maintenance of staff training records and resumes.
    • Facilities: Laboratories, animal holding and test areas, storage areas for materials and test/control articles and archives.
    • Animal Care: Pre-study activities, the IACUC, housing, water, feed and bedding.
    • SOPs: Writing, approval and dissemination of SOPs, training of personnel on procedures and change control.
    • Computerized systems: Qualification, including installation, operational and performance, validation of key equipment, apparatus and computer programs, and the role of IT personnel in GLP studies.
    • Raw data: Analysis and reports, traceability of records, data integrity, documents needed for a patent application, instrument calibration, use, maintenance and repair log books, and retention periods during archiving.

    Section 4: Implementing GLPs:

    • Conducting a GLP audit and what it can tell you
    • Basic elements of a quality system
    • Writing and implementing SOPs
    • GLPs in a mixed-GxP environment
    • GLPs for the smaller organization or independent investigator

    Section 5: Study Director


    • Responsibilities of the study director
    • Protocol development
    • Subject matter expert
    • SOPs and study method development
    • Data interpretation and analysis
    • Investigations and corrective and preventive actions (CAPAs)
    • Study reports and amendments
    • The compliance statement
    • Archiving of laboratory data
    • Role in regulatory inspections
    • Role in multisite studies

    Section 6: Quality Assurance

    • Master schedule
    • Management's representative in the laboratory
    • Auditor
    • Types of inspections and audits
    • Audit plans and schedules
    • Audit reports
    • The QA statement
    • Role in regulatory agency and client inspections
    • Role in multisite studies

    Section 7: Regulatory Inspections

    • Guidance documents and regulatory resources
    • The FDA GLP inspection program
    • Foreign inspections
    • Responsibilities for compliance
    • Review and analysis of FDA inspectional findings

    Section 8: GLP Inspection Observations (Workshop)

    • Identifying noncompliance
    • Writing clear observations of noncompliance
    • Responding to observations

    Section 9: Emerging Issues

    • FDA challenges
    • Harmonization of worldwide practices
    • Quality system inspection techniques
    • Quality by design
    • Proposed revisions to GLP

  • Testimonials

    "This course was much better than other versions of GLP training I've taken as it was much more comprehensive.  I really enjoyed the Course Director's examples of relevant happenings to support the material she was covering."

    Amy H., General Manager, Woods End Laboratories


    "There was a lot of useful information. The examples and references to our own situations helped us understand how to apply content.”

    Brenna F., Quality Assurance Auditor, The Jackson Laboratory


    "We have had extensive training in the webinar setting, but this was much more comprehensive as a course setting. The information was presented in a very clear and detailed manner, in line with other information we have pulled in from consultants."

    Dr. Jaime L., Associate Manager, Regulatory Services, GENEWIZ


    "The Course Director is an excellent instructor and I really liked that he was willing to engage in so much discussion and question/answers."

    Jana M., Quality Consultant, McCulloch Quality Consulting LLC


    "I really enjoyed the class. It was easy to interact and ask questions. The materials (binder, etc.) provided are great! They will be a wonderful reference for our lab."

    Melissa R., Research Asst. III, Wyss Institute


    "The Course Director brought a new perspective to training which I have received (repeatedly) over my 26 years in the small molecule pharma industry – the discussion was fresh! The most interesting GLP training I have attended in years."

    Susan L., Quality Control Scientist, Incyte


    "Very well done. The fact that the course director is an experienced scientist made a big difference."

    Stephen T., CEO, Protea Biosciences


    "The course material was very informative and obviously reflected current industry thinking and practices. The instructor was also able to share and discuss real-life situations."

    Christine C., Deputy Director, RD/QA


    "Overall, I was impressed by the entire package, and I found the course of great utility."

    Matthew P., Director, R&D, Protea Biosciences


    "I really enjoyed the extensive information in this course. I highly recommend it to anyone in the scientific industry. It has been a great experience."

    Cecilia S., Scientific Associate II/, Qiagen Sciences


    "The course director made the course very informative with real life anecdotes. This was a great class!"

    Deepa D., Lab Operations Specialist, Canon US Life Sciences


    "The course director did a great job. He was complete in his explanations and was able to keep our attention. Very informative."

    Brooke H., Research Scientist, Celsense, Inc.

Frequently Asked Questions

  • Is GLP Similar to GMP for Laboratories?

    They are similar in many ways, especially in the area of documentation. However, GLPs focus on the reliability of data that is generated during the development of potential products during research studies, while GMPs focus on the reproducibility of products, either near the end of the research effort or after the product has been approved for marketing.

  • Can the Quality Assurance Auditor be Part of the Technical Staff That Performs the Study?

    No! The GLP Regulations clearly state that Quality Assurance must be independent from the Study Director. Since the Study Director supervises the technical performance of the study, the Auditor cannot be part of the study group. A government inspector always checks to be certain that QA is independent from the study group.

  • Must You Show Quality Assurance Audit Findings and Corrective Action to an FDA Inspector?

    No, you do not. An inspector can ask to see audit findings, but audit reports do not have to be presented. A sponsor must show proof that studies, facilities and data were audited at appropriate intervals, but actual findings can be withheld.

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.