Currently, more and more laboratories are run like businesses, where success is driven by credibility. In order to be credible in the current competitive environment, your laboratory must:
- Produce reliable and accurate results with unambiguous test reports
- Deliver correct information to the correct customer in a timely manner
- Perform economically and efficiently
- Be able to retrieve historical records and data
- Operate independently in quality assessment
- Withstand audits and inspections
Critically, the loss of credibility in a laboratory leads to customer skepticism and a loss in confidence of your capabilities. Without Good (Quality Control) Laboratory Practices – G(QC)LP – you are left focusing on “defending” results, and regulatory or external pressure which distract personnel from value-adding and cost-effective operations. This course will help you and your laboratory perform successfully by providing you with knowledge and the understanding needed to establish and maintain G(QC)LP.
- List the key elements and basic principles that are necessary to establish proper control and sustain compliance in a Quality Control / Analytical Laboratory
- Understand the difference(s) between Out Of Specification (OOS) and (Out Of Trend) OOT
- Explain the essential steps in conducting OOS / OOT investigation, including the criteria of re-testing and re-sampling
- Know how to document the outcome of OOS / OOT investigation
- State your role and responsibilities regarding G(QC)LP compliance
You will benefit from this training if you are a regulated laboratory analyst or supervisor, or if you have a general 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 1 full day session with breaks.
PDF Certificates will be provided to participants electronically.
Each participant will attend 1 full-day session. The date is to be confirmed (TBC).
|TBC||October 2020||8:45am join for 9:00am-5:00pm|
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 $695.50 per participant
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.
Contact us for clarification or to discuss your interest in this course.