Industry 4.0 (the Fourth Industrial Revolution) is happening now and the COVID-19 pandemic has accelerated the speed of advancement in modern smart technology and its application.

You may have heard of ISPE Pharma 4.0TM and maybe you are thinking that this only applies to the Pharmaceutical industry. Industry 4.0 and the overlaying quality and regulatory requirements is far more encompassing than just Pharma.

The MTP 4.0 (Medical Technology, Biotechnology and Pharmaceutical) training course provides a comprehensive overview of all aspects of Industry 4.0 for regulated industries.

MTP 4.0 Banner with doctor using tablet and digital interface references


Through this course you will develop an understanding of:

  • The key terms, technologies and processes
  • Maturity models that allow the transition for a short, medium and long term digital strategy
  • A Holistic Control Strategy for changes to the Quality Management systems
  • Validation 4.0 – for streamlining the validation processes
  • The importance of Process Maps and Critical Thinking
  • Continuous Process Verification, Process Automation and Data Analytics
  • Plug and Produce technologies
  • The importance of a Management Communication Strategy
  • The enablers for data, storage and speed
  • Cybersecurity

This course intends to bring you up to speed with Industry 4.0 and its application in the healthcare setting to get you thinking about opportunities within your company/industry for innovation and improvement. The course focusses on sharing thought-provoking developments in industry, rather than upskilling.


Anybody keen on understanding Industry 4.0 and its potential for the Medical Technology, Biotechnology and Pharmaceutical sector will be interested in the content.

If you are innovative, a future-thinker and want to be a ‘champion for change’ within your company to adopt the latest technology, you can benefit most from this training.

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). Training will be delivered by the trainer sharing their screen of the PowerPoint presentation.

The training is delivered as 2 x 3.5 hour sessions over 2 days. Breaks are included.

A digital credential (badge) will be issued via Credly on e-mail to recognise successful training completion.

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.


Participants will attend both half-day sessions:

 Sessions  Dates  Times
 Day 1  13th April 2023  8:30am-1:00pm
 Day 2  14th April 2023  8:30am-1:00pm

Times are based on Melbourne, Australia.

Fee and Discount
  • AUD $700 (excluding GST) per participant
    • A 10% discount applies for 3 or more participants from the same company

New Session Dates To Be Advised

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

Refer to the Terms and Conditions