Conducting internal audits is an integral component of instituting, sustaining, and enhancing your quality system, a pivotal element for the success of your business. Whether you are part of a pharmaceutical company aligning with the "self-inspection" prerequisites outlined in the PIC/S Guide to Good Manufacturing Practice (GMP) or a medical device company adhering to the "internal audit" specifications of ISO 13485, implementing an internal audit program across your organization serves multiple purposes. It not only imparts knowledge to personnel but also reinforces accountability for various elements within the quality system, fostering a culture of continuous improvement and driving cost reductions.
The value derived from internal audits remains consistent regardless of the maturity level of your organization's quality system. If you find yourself seeking ways to optimize and extract more value from your self-inspection/internal audit program, this course is tailored to assist you in achieving your Key Performance Indicators (KPIs).
Content
Day 1
- 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
Day 2
- 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
- CAPA
- Audit verification
Participants
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.
Sessions
| Sessions | Dates | Times |
| Day 1 | 21 August 2024 | 8:45am join for 9am-5pm |
| Day 2 | 22 August 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 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 biju.kishor@seerpharma.com.au
Contact us to discuss your interest in a public or private delivery of this course.
