International GMP regulators continue to find GMP deficiencies in organisations related to Out‐of‐Specification (OOS) handling. 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)
GMP inspectors are scrutinizing how companies manage Out-of-Specification (OOS) results, and one of the primary objectives of this course is to facilitate your understanding of the current best practices for conducting OOS investigations.
Beyond OOS handling, Data Integrity (DI) stands out as another prominent topic in the industry, particularly within QC laboratories. Despite the surge in industry guidance on DI since 2016 from regulatory bodies like the FDA, WHO, MHRA, PIC/S, ISPE, and PDA, it's important to note that the demonstrable integrity of data and records has been a long-standing GMP requirement.
This two-day course will guide you through the essential elements and fundamental principles for maintaining compliance in QC laboratories, placing specific emphasis on OOS handling and Data Integrity. A critical factor for QC laboratories and regulators alike is the successful validation of methods. It is imperative to ensure that the test methods and the data generated by the laboratory are reliable. Consequently, this course will concentrate on the key elements integral to the successful validation of test methods.
Day 1 - Overview of Laboratory Controls & OOS/OOT Handling
- 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), Out‐of‐Trend (OOT) and Out of Expectation (OOE)
- Best practices and process for conducting successful OOS investigations, including the use of re‐testing and re‐sampling
- Statistical approach when considering the trend data
- Regulators’ perspectives
Day 2 - Analytical Method Validtion
- Overview of analytical method validation
- Basic statistical tools for method validation
- Key performance characteristics of analytical methods
- Analytical Method- Fit for purpose
- Design an analytical method validation
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 full day sessions with breaks.
PDF Certificates will be provided to participants electronically.
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
| Sessions | Dates | Times |
| Day 1 | 3 July 2024 | 8:45am join for 9am-5pm |
| Day 2 | 4 July 2024 | 8:45am join for 9am-5pm |
Times are based on Singapore time (SGT): UTC +8:00.
Participants to join at 8:45am in advance of a 9:00am start to address any technical issues.
Fee
- SGD $1400 (excluding tax) per participant
- A 10% discount applies to 3 or more participants from the same company
Course Registration and Payment
To register, please contact Biju Kishor at biju.kishor@seerpharma.com.au
Contact us to discuss your interest in a public or private delivery of this course.
