Internal audits deliver value irrespective of how mature your organization’s quality system is. Do you need help optimizing and delivering more value from your self-inspection / internal audit program? This course can help you achieve your KPIs.
- Critical role of quality audit in GMP compliance & improvement
- Regulatory standards and guidelines for quality auditing
- GxP requirements for internal audit programs
- Risk assessment as it applies to quality audit practices
- Documents, records & data for effective audits
- GxP audit schedules and the use of risk management in relation to prioritizing audits
- Six fundamental steps of auditing explained in detail (including tips on how to manage & facilitate audits in a constructive manner)
This course is designed for operational personnel (key operators, supervisors and managers) who have a key role in quality systems implementation and will assist them to develop a system of quality audit.
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||September 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.