International GMP regulators like the FDA, TGA and Medsafe continue to find GMP deficiencies in organisations relating to Out Of Specification (OOS) events. The citations range across:
- Inadequate management (no SOP or not following the SOP)
- Inadequate investigation (lack of depth or lack of documentation)
- Inadequate outcomes (testing into compliance without (justifiably) invalidating the OOS)
As such, regulatory GMP inspectors are looking into how companies handle out of specification results and this course is designed to help you understand the current best practice for OOS investigations.
Content
The course will focus on:
- A Quality Management System for Laboratories - Introducing ISO 17025
- Operational processes and procedures
- Management reviews, audits, improvement
- Roles and responsibilities, personnel
- Instruments, method validation, calibration
- Reference materials and sample management
- Laboratory test results, failure investigation, corrective action
- Quality Control
- Out of Specification
- Difference(s) between Out Of Specification (OOS) and Out Of Trend (OOT)
- Best practice process for conducting successful OOS investigations; including re-testing and re-sampling
- Special requirements for microbiological/biological OOS events
- Case studies and investigation insight
- Criticality of documentation
- Regulator's perspective
Participants
You will benefit from this training if you are a regulated laboratory analyst or supervisor/manager, or if you have an interest in GxP and laboratory practices.
Format and Course Length
The course will be delivered as an online virtual-classroom training session.
Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.
The training will be delivered as 2 x 3.5 hour sessions over 2 days. Breaks are included.
What Do I Need?
Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.
Sessions
Participants will attend both half-day sessions:
| Sessions | Dates | Times |
| Day 1 | 15th May 2023 | 9:00am-12:30pm |
| Day 2 | 16th May 2023 | 9:00am-12:30pm |
Times are based on Melbourne, Australia.
Fee and Discount
- AUD $700 (excluding GST) per participant
- A 10% discount applies for 3 or more participants from the same company
New Session Dates To Be Advised
Contact us to discuss your interest in a public or private delivery of this course.
