Course Descriptor

As Pharma 4.0 brings with it a shift toward digitalisation, more and more businesses are implementing digital calibration processes. Evolving technology has meant that life science businesses can now do more with, and learn more from, their process data than ever before.

Identify the key points that you need to consider when preparing your business to transition from traditional manual calibration processes to automated digital processes. Enable yourself to better manage and utilise data and ensure that you remain compliant with the various regulatory requirements in the life science sector.

Learn what impact digital calibration processes may have on the future of the life science sector and how you can utilise these processes to the benefit of your business.

This talk is aimed at individuals working in the life science sector who want to better understand the changing trends related to calibration within their industry.

You may be:

  • Focusing on improving traceability, data integrity or efficiency within your process.
  • Exploring better, more modern, or more efficient methods of work.  
  • Considering if your business should implement a digital calibration process. If so, why should you do this? And how do you start?
  • Looking to better understand what considerations you should take on board when trying to transition your business from a traditional, manual calibration process, to an automated digital process.
  • Interested in learning how digital platforms and technology have evolved over the years, to better enable businesses to remain compliant and meet regulatory requirements such as FDA’s 21 CFR part 11.

Content will cover:

  • The need to remain compliant with GXP, GMP, and FDA regulatory requirements.
  • Ensuring compliance relating to GAMP, ALCOA, Quality Systems, ISO17025, Calibration systems and the shift towards digitalisation
  • Future systems relating to industry 4.0, IOT, robotics, automation, big data, and AI

Course Delivery Method: Morning classroom session and afternoon practical session

Course Delivered By: Sami Koskinen and Michael Frackowiak (Beamex)

Price: €999

 

 

Calibration 4.0 Digital by Design with Beamex

SKU: Calibration-4.0-Digital-by-Design-Beamex Category: Tags: ,

999.00

Out of stock

Dates:
Fee:
€999
Suitable for:

This course is suitable for:

Maintenance managers, continuous improvement managers, innovation managers, engineering managers, digitalisation managers, quality managers, E,C & I Lead or a reliability representatives

Who should attend

This course is suitable for:

Maintenance managers, continuous improvement managers, innovation managers, engineering managers, digitalisation managers, quality managers, E,C & I Lead or a reliability representatives

Key topics covered

Morning Classroom Session:

Why do we calibrate?

Good Automated Manufacturing Practice in Life Science

Data Management and Data Integrity

Quality Implications 

Our Vision for the Digitalisation of Calibration for Pharma 4.0

Integrated Systems

Data Analytics

How we see the future

 

Afternoon Practical Session:

Digital calibration processes

Auditability

Considerations for 21CFR part 11 compliance

Learning outcomes

Understanding of current most widespread issues related to manual calibration processes in the life science sector

How digital processes can be utilised to ensure compliance

Key areas of focus for moving to a digital calibration process

How digitalisation has impacted the life science sector and the benefits it has brought

What new technologies such as IOT, robotics, automation, big data, and AI can bring to the calibration process of the future

A better understanding of what the digitalisation of calibration processes can mean for your business

Assessment

 

 

 

Discover our world class campus facilities