Course Code: CPD/O/11/2021

CPD Hours: 14

As a pharmaceutical or medical device company, you are required to investigate the cause of quality failures or production problems. However, “failure to thoroughly investigate…” is a common finding from regulatory inspections. In this course, you will learn how to conduct effective failure investigations and perform Root Cause Analysis (RCA) using real-life scenarios from industry and gain a clear understanding that the more structured your investigation process is, the more effective it will be. Then, you will learn how to use the Corrective Action and Preventive Action (CAPA) system, not just to satisfy regulatory requirements, but to implement a closed-loop system for problem solving that will help to minimise product quality issues and improve compliance.

gloved-GMP-operators-removing-tablets-from-blisters

Content
Root Cause Analysis
  • 8D History
  • Comparison of 8D with 6-sigma DMAIC and PDCA
  • Concept of variation in a problem-solving process
  • 8D Problem-Solving Approach using a combination of techniques such as,
    • 5 WHY’s
    • IS versus IS NOT
    • 5Ws + 1 H
    • Ishakawa Analysis
    • Failure Mode Effect Analysis (FMEA)
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

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

Participants will attend both full-day sessions.

 Sessions  Dates  Times
 Day 1  10 October 2022  9:00am-5:00pm
 Day 2  11 October 2022  9:00am-5:00pm

Seats are limited: Only 25 participants per class

Fee and Registration
  • HKD $4800 per participant
    • A 10% discount applies for 3 or more participants from the same company

To register, please contact Biju Kishor at Biju.kishor@seerpharma.com.au 

Refer to the Terms and Conditions

Shruti Circle Gradient Grey BG 182x182

Proposed Trainer

Shruti Narayana

Shruti has over 15 years of rich experience in quality management in the pharmaceutical industry with reputable companies in Southeast Asia and India and extensive experience in setting up and managing quality systems for manufacturing, packaging & distribution of pharmaceutical products assuring high quality standards as well as regulatory compliance. Shruti also has a comprehensive understanding of all aspects of quality management including manufacturing, validation, documentation, technology transfer, investigations, complaints, product recalls & returns, change control and product quality reviews as well as software packages like TMS quality compliance software, Blue Mountain calibration & maintenance software and QS Doc electronic documentation management system. Shruti can collaborate with management teams and contribute to the development of new products, engineering designs, manufacturing & training methods for continual improvements in quality & productivity. Shruti can communicate in Hindi.