As a pharmaceutical or biotech or medical device company, the obligation to investigate the causes of quality failures or production issues is paramount. Yet, regulatory inspections often reveal a common finding: "failure to thoroughly investigate." This course is designed to equip you with the skills to conduct meticulous failure investigations and proficiently perform root cause analyses. Real-life scenarios from the industry will be employed to provide practical insights. The course emphasizes that the more structured your investigation process, the more effective it will be.
Additionally, the program delves into the strategic utilization of the Corrective and Preventive Action (CAPA) system. Beyond meeting regulatory requirements, this system is explored as a tool to establish a closed-loop mechanism for problem-solving. By integrating CAPA effectively, you can not only address immediate concerns but also institute a proactive approach to minimize product quality issues and enhance overall compliance. Practical examples and case studies will be employed to illustrate the tangible benefits of implementing a robust CAPA system.
Content
Day 1: Root Cause Analysis
- General principles of 8D problem analysis methodology
- Comparison of 8D with 6-sigma DMAIC and PDCA
- Concept of variation in a problem-solving process
- Key steps of an 8D problem analysis methodology
- Common methods used for problem solving
- Develop an 8D report for an identified problem
Day 2: Corrective Action and Preventive Action (CAPA)
- Regulatory background of Corrective Action and Preventive Action (CAPA)
- Definition of CAPA
- Integration of CAPA with key quality system elements
- Link the concept of risk with CAPA management
- Understand the SMART principles of CAPA
- Elements of a compliant and effective CAPA System
- Develop a CAPA plan from the outcome of RCA using 8D approach
Participants
This course has been designed for all those who are involved in failure investigations and corrective actions. You will benefit from this program whether you are new to formal problem solving and CAPA or are a more experienced professional. It is expected that you are familiar with regulatory GMP and Quality Management System requirements within the pharmaceutical and/or medical device industries.
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 | 15 April 2024 | 8:45am join for 9am-5pm |
| Day 2 | 16 April 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
- 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.
