Industries: Pharma / BiotechMedical Device

Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies

Course Director: Susan Meeker

Course Fee: $2650.00 Regular Registration / $2450.00 Early Bird (30 Days in Advance)

Course Description -

This course will provide participants with a comprehensive understanding of the terminology, regulations and mandated practices for conducting a study in compliance with GLP regulations.  Those attending will get a thorough briefing of the relevance of accurate documentation, calibration and maintenance of instruments, and validation of relevant methodologies. 

The course also covers in detail issues involving the roles and responsibilities of the Test Site Management and the Study Director in planning, supervising, and managing nonclinical studies.  The requirements for training of staff, good documentation practices, study protocols and reports, and standard operating procedures will be examined. Requirements for equipment such as qualification (installation, operational, and performance) and maintenance will be discussed.  The special requirements for the facilities including the archives will be discussed. The requirements for the conduct of the GLP compliant laboratory study to assure animal welfare, data integrity, and thorough chain-of-custody of specimens and materials will be discussed.

Also included is a discussion of the functions of the Quality Assurance Unit (QAU) and the need to effectively audit laboratory activities and data for compliance to GLP regulations and internal SOPs and test methods.  Successful audits are the result of good planning and effective communication between QA staff and management.  This course will cover a range of audit activities that must be conducted to assure management that laboratory studies are performed in compliance to the regulatory standard stated in the study protocol.

The responsibilities of Quality Assurance in the monitoring of laboratory activities during data collection, analysis, and archiving of study information will be discussed.  The roles of the Study Director and QA in regulatory and client inspections will also be presented.

The course also discusses how to manage regulatory inspections, and how to respond to findings of non-compliance noted during a regulatory agency inspection.  Inspection results for sponsor companies and CROs are included in these discussions.

Who Should Attend

Good Laboratory Practices (GLP) generally refers to a quality system of management controls for laboratories and research organizations that regulates how nonclinical safety studies are planned, performed, monitored, recorded, reported and archived.  Many bioanalytical laboratories have also chosen 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 US FDA, US EPA, and other national regulatory agencies.

This three-day GLP training course is designed for all Scientists (managerial and laboratory), Regulatory Affairs and Compliance personnel who actively participate in regulated laboratory studies.  It will be of most benefit to professionals whose job function necessitates the generation, evaluation, assurance, and submission of laboratory data to regulatory agencies.  Principal Investigators, Study Directors, Study Monitors, and professionals aspiring to these positions will derive benefit from this course.

This course is also useful for quality assurance and quality control managers, coordinators of multi-site projects, regulatory affairs professionals, auditors, and senior management interested in effective QA techniques.  New and experienced staff from the food, pharmaceutical, medical device, nutraceutical, agrochemical, and cosmetics industries will learn the fundamental principles and applications of GLP, particularly in the complex multi-site environments of today’s industry.  The course will also benefit professionals from CROs that operate under the GLP regulations..

First Day

Section 1: Introduction: The GLPs

  • Historical perspective & 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 & Personnel
  • Subpart C – Facilities
  • Subpart D – Equipment
  • Subpart E – Testing Facility Operations
  • Subpart F – Test & Control Articles
  • Subpart G – Protocol & Conduct of a Nonclinical Laboratory Study
  • Subpart J – Records & Reports
  • Subpart K – Disqualification

Section 3: It Starts at the Top – Organization, Management & 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; multi-site studies
  • Requirements for training of staff and documentation of training: certification for employees, job competency standards, job descriptions, continuing education programs and periodic refreshers; Maintenance of staff training records and resumes
  • Facilities: Laboratories; Animal Holding and Test Areas; Storage Areas for materials and test/control articles; Archives
  • Animal Care: Pre-study activities; The IACUC; Housing, Water, Feed and Bedding
  • SOPs: Writing, approval and dissemination of Standard Operating Procedures (SOPs); training of personnel on procedures; change control
  • Computerized systems: Qualification (installation, operational and performance) and validation of key equipment, apparatus and computer programs; 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; retention periods during archiving

Second Day

Section 4: Implementing GLPs:

  • Conducting a GLP audit and what it can tell you
  • Basic elements of a quality system
  • Writing & 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 CAPAs
  • Study Reports and Amendments
  • The Compliance Statement
  • Archiving of Laboratory Data
  • Role in Regulatory Inspections
  • Role in Multi-site Studies

Section 6: Quality Assurance

  • Master Schedule
  • Management's Representative in the Laboratory
  • Auditor
  • Types of inspections and Audits
  • Audit Plans and Audit Schedules
  • Audit Reports
  • The QA Statement
  • Role in Regulatory Agency and Client Inspections
  • Role in Multi-site Studies

Third Day

Section 7: Regulatory Inspections

  • Guidance documents and regulatory resources
  • The FDA GLP Inspection Program
  • Foreign inspections
  • Responsibilities for compliance
  • Review & 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

Learning Objectives

By the end of this three-day course, attendees will have a strong understanding of the fundamental compliance requirements for Good Laboratory Practices. While the focus of this course is the US FDA GLP regulation, Title 21, Code of Federal Regulations Part 58, other standards such as the US EPA GLPs, OECD GLP principles, and other international regulations will also be presented as a 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 non-compliance will be examined, including a thorough review of examples of previous FDA inspectional findings.

Testimonials

"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

I hear that GLP is just like GMP for laboratories. Is this true?

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 Quality Assurance Audit findings and corrective action be shown to an FDA inspector?

No, they 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.

Video

>

CfPIE Good Laboratory Practices (GLP) Course

Meet Ken Cleaver, CfPIE's Course Director for " Good Laboratory Practices (GLP) for Pre-Clinical Testing". Ken gives a snapshot of the 3-day classroom course which focuses on understanding the terminology, regulations and mandated practices for GLP testing and compliance.