Get Certified
CERTIFICATION
Organizations equipped with an audit force capable of performing risk-based GMP six-system style assessments rarely encounter surprises during an inspection that lead to regulatory action. Our Investigator certification series is designed using the risk-based approach utilized by the regulators to efficiently uncover, document, and communicate deviations from regulatory expectations, with the goal of ensuring the end-to-end operations consistently operate as designed and produce a high quality product with low levels of error.
This 3-part training series focuses on enhancing our ability to think critically in unfamiliar circumstances, under pressure, and considering significant time constraints. Join us as we share best practices and work through hands-on case studies in a real GMP production & laboratory environment.
The primary outcome of this series will be the ability to identify, pursue, document and communicate observations in an efficient and meaningful manner following PIC/s guidelines, while framing the observation in the context of patient safety to ensure time and energy is not wasted on low-risk deficiencies.
Each Level will feature classroom instruction combined with hands-on exercises within the Northeastern GMP manufacturing and testing facility.
Check out the AGENDA here
Meet us at the Northeastern University Innovation Campus at Burlington in 2025!
Level 1 — Inspector
Our two-day Level 1 Inspector workshop is designed to prepare participants with the knowledge and experience necessary to conduct effective risk-based six-system audits used by the regulators to detect, document, and communicate deficiencies. In this course, we introduce the trigger-target-finding approach to inspection, which allows the inspector to uncover deficiencies that would not be detected without making connections between related elements from different sources. Participants will learn to develop their own critical thinking checklist so that serious deficiencies within the design, operation, and/or monitoring of a GXP system are not overlooked during an inspection, and develop the confidence necessary to perform comprehensive assessments within a limited timeframe.
Topics addressed in this course include:
Highlights of the six-system approach to inspection
Take-aways from current PIC/s harmonized guidance for inspectors
Connecting elements from unrelated data sets to uncover meaningful observations
Forming observations using the trigger-target-finding approach to inspection
Technical writing for effective communication
ICH Q9 and its application to inspection
Live Oak Level 1 Inspector Certification can be achieved by participating in the optional and included post-workshop evaluation. Details for Level 1 Inspector Certification examination will be discussed further during the workshop.
Level 2 — Advanced Inspector
Our two-day Advanced Level 2 Inspector course builds on the risk-based techniques developed in Level 1 by performing deep dives into each of the six systems, with a special emphasis on detecting breaches in data integrity. We discuss recent regulatory actions through reconstructing the inspection approach that led to the finding of critical observations. In this course, we introduce effective techniques to detect, develop and communicate data integrity observations.
Topics addressed in this course include:
Reconstruction of recent regulatory action
Effective inspection techniques to detect breaches in data integrity
Effective interviewing
Live Oak Level 2 Advanced Inspector Certification can be achieved by participating in the optional and included post-workshop evaluation. Details for Level 2 Inspector Certification examination will be discussed further during the workshop.
Level 3 — Forensic Data Integrity Investigator
This advanced one-day forensic investigator course builds on the investigative techniques gained in Levels 1 and 2, with the added topics of effective strategies for the forensic evaluation of unfamiliar data sets, complex software, and data sets only available in a foreign language. This advanced course is structured into various modules throughout the day; with each module consisting of an introductory lecture followed by hands-on case studies performed individually and within small groups. Topics addressed in this course include:
Evaluating Paper and Hybrid Systems for breaches in Data Integrity
Evaluating records in a foreign language
Detecting patterns in data
Techniques for review of complex audit trails
Highlights of current regulatory guidance for data integrity
Live Oak Level 3 Forensic Data Integrity Investigator Certification can be achieved by participating in the optional and included post-workshop evaluation. Details for Level 3 Inspector Certification examination will be discussed further during the workshop.
Level 1 — Inspector (Copy)
Our two-day Level 1 Inspector workshop is designed to prepare participants with the knowledge and experience necessary to conduct effective risk-based six-system audits used by the regulators to detect, document, and communicate deficiencies. In this course, we introduce the trigger-target-finding approach to inspection, which allows the inspector to uncover deficiencies that would not be detected without making connections between related elements from different sources. Participants will learn to develop their own critical thinking checklist so that serious deficiencies within the design, operation, and/or monitoring of a GXP system are not overlooked during an inspection, and develop the confidence necessary to perform comprehensive assessments within a limited timeframe.
Topics addressed in this course include:
Highlights of the six-system approach to inspection
Take-aways from current PIC/s harmonized guidance for inspectors
Connecting elements from unrelated data sets to uncover meaningful observations
Forming observations using the trigger-target-finding approach to inspection
Technical writing for effective communication
ICH Q9 and its application to inspection
Live Oak Level 1 Inspector Certification can be achieved by participating in the optional post-workshop evaluation. Details for Level 1 Inspector Certification will be discussed further during the workshop.
