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.

CAPA is a well-known CGMP regulatory concept that focuses on investigating, understanding, and correcting discrepancies while attempting to prevent their recurrence.”
FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations, 2006

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This root cause analysis and CAPA training course will help you perform thorough investigations leading to value-adding actions that improve your business.

Content

Through work-shops you will learn how to conduct effective failure investigations and perform root cause analysis 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 CAPA system, not just to satisfy regulatory requirements, but to implement a closed-loop problem solving system that will help minimise your product quality problems and improve your compliance.

At the end of the course you should be able to:

  • Understand the language of investigation, problem solving and CAPA
  • Identify regulatory requirements and expectations related to failure investigation, root cause analysis (RCA) and CAPA
  • Know when to use risk assessment
  • Outline the steps in a common failure investigation and RCA process
  • Understand when and where to apply problem solving methods and tools
  • Document failure investigation and RCA process activities
  • List the essential features of effective CAPA systems
  • Ensure your CAPA process is efficient and effective
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 you 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 is delivered as 2 x 3.5 hour sessions over 2 days. Breaks are included.

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 half-day sessions:

 Sessions  Dates  Times
 Day 1  2nd June 2021  8:45am join for 9:00am-12:30pm
 Day 2  3rd June 2021  8:45am join for 9:00am-12:30pm

Times are based on Melbourne, Australian Eastern Standard Time (AEST) / Coordinated Universal Time (UTC) +10:00

Participants to join at 8:45am in advance of a 9:00am start to address any technical issues.

Fee and Discount
  • AUD $600 (excluding GST) per participant; introductory offer
    • A 10% discount applies for 3 or more participants from the same company

New Session To Be Advised

Contact us for clarification or to discuss your interest in a public or private delivery of this course.

Refer to the Terms and Conditions

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Proposed Trainer

Michelle Peake

Michelle has over twenty-five years of experience (including Australia, UK, Malaysia and Indonesia) in bioprocessing, specialising in Project Management, Business Development, cGMP manufacture (Upstream and Downstream), Quality (QA and QC) and Technology Transfer for mammalian cells, insect cells and bacteria. Michelle’s operational experience also includes laboratory design and build, encompassing the design and construction of a cGMP compliant biologics manufacturing facility in Penang, Malaysia. Michelle has a significant amount of experience dealing with suppliers and manufacturers in Asia and has inspected a number of facilities in region on behalf of the companies that she has worked for. In addition, Michelle has overseen and managed operations for inspections from regulators such as the MHRA (UK).