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.
The course will focus on:
- Key elements and basic principles that are necessary to establish proper control and sustain compliance in a Quality Control / Analytical Laboratory (ISO 17025)
- 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
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.
Participants will attend both half-day sessions:
|Day 1||7th September 2022||9:00am-12:30pm|
|Day 2||8th September 2022||9:00am-12:30pm|
Times are based on Melbourne, Australian Eastern Standard Time (AEST) / Coordinated Universal Time (UTC) +10:00.
Fee and Discount
- AUD $700 (excluding GST) per participant; introductory offer
- A 10% discount applies for 3 or more participants from the same company
Contact us to discuss your interest in a public or private delivery of this course.