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)
As such, GMP inspectors are looking into how companies manage OOS results and one of the objectives of this course is to help you understand the current best practices for OOS investigations.
Besides OOS Handling, Data Integrity (DI) is another hot topic in the industry, including QC laboratories. While there is a flood of industry guidance on DI since 2016 (from the FDA, WHO, MHRA, PIC/S, ISPE and PDA), demonstrable integrity of data/records has been a long‐standing GMP requirement, it is not new.
This 2‐day course will step you through the key elements and basic principles for sustaining compliance in QC laboratories, with specific focus on OOS Handling and Data Integrity.
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) and Out‐of‐Trend (OOT)
- Best practices and process for conducting successful OOS investigations, including the use of re‐testing and re‐sampling
- Regulators’ perspectives
Day 2 - Data Integrity
- What does data integrity (DI) mean, who can contribute to good DI?
- Why is data integrity and security such a hot topic for regulators?
- Data criticality and data risk
- Integration of DI into your QMS using a risk‐based approach
- Protection and security of raw data and original records
- Developing practical audit and remediation strategies for DI
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.
|Day 1||5 Sept 2023||8:45am join for 9am-5pm|
|Day 2||6 Sept 2023||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.
- 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 email@example.com
Contact us to discuss your interest in a public or private delivery of this course.