Internal audits are a fundamental part of implementing, maintaining, and improving your quality system which is critical to your business’ success. Whether you work for a pharmaceutical company complying with “self-inspection” requirements of the PIC/S Guide to GMP or a medical device company complying with “internal audit” requirements of ISO 13485, deploying an internal audit program throughout your organisation will help educate personnel, confirm ownership of various quality system elements, and ultimately drive continuous improvement and cost reductions.
Internal audits deliver value irrespective of how mature your organisation’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.
- Managing Internal Audits
- Critical role of quality audits in compliance & improvement
- Regulatory standards and guidelines for quality auditing
- GMP and Quality System requirements for internal audit programs
- Risk Assessment as it applies to quality audit practices
- Documents, records and data for effective audits
- Audit schedules and the use of risk management in relation to prioritizing audits
- Techniques and tips for auditing - 6 fundamental steps of auditing
- Corrective and Preventive Action (CAPA) in Internal Audits
- What is Corrective and Preventive Action (CAPA)
- How to apply CAPA to quality audits
- How to apply Risk Management principles to:
- Audit observations
- Audit verification
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 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||22 November 2023||8:45am join for 9am-5pm|
|Day 2||23 November 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.
Fee and Discount
- SGD $1,400 (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 firstname.lastname@example.org
Contact us to discuss your interest in a public or private delivery of this course.