This course aims to help identifying regulatory requirements and expectations related to failure investigation, root cause analysis (RCA), and CAPA. The CAPA system not only to satisfy regulatory requirements but also to implement a closed-loop problem-solving system to help minimize quality issues and improve compliance.

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Content
  • Key steps and activities for an 8D problem analysis
  • General principles and approach for 8D problem analysis
  • General principles and approach for the use of FMEA in problem analysis
  • general principles and approach for the use of Fish Bone Diagram in problem analysis
  • Key steps and activities of risk management in problem analysis
  • CAPA elements and principles
  • Develop a CAPA form for observations / deficiencies
  • DMAIC approach of problem solving
  • Understand the SMART principles of CAPA
  • Link the concept of risk with CAPA management
Participants

Managers and supervisors responsible for GMP compliance, root cause analysis, failure investigations, and CAPA strategies will benefit from this program.

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.

Sessions

Each participant will attend both full-day sessions.

 Sessions  Dates  Times
 Day 1  09 November 2020  8:45am join for 9:00am-5:00pm
 Day 2  10 November 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.

Fee
  • SGD $1,300 (excluding GST) per participant
    • A 10% discount applies to 3 or more participants from the same company
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.

Course Registration and Payment of Fee

Please contact Shanice Pan at shanice@seerpharma.com (DID: +65 6914 9068)

Contact us for clarification or to discuss your interest in this course.

Refer to the Terms and Conditions