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  • Process & performance improvement
  • Regulatory compliance
  • Engineering, facilities & technology
  • Supply chain integration

DAY 1, 1 December 2014

08:00-08:20
08:20-08:30
08:30-09:15
keynote

Implementing PAT, MES and cloud based systems to significantly increase compliance with regulatory requirements and optimise business processes

  • Increasing flexibility and time to market through advancements in the latest single use technologies and modular facility design to withstand the unstable market
  • Assessing the deployment of PAT and MES within two pharma companies and why  investment in this market is spreading
  • Learning from the automotive industry  forecasting systems which enables just-in-time delivery to improve ROI by reducing in-process inventory and associate costs


09:15-09:50
achieving manufacturing excellence

Reducing process variability and identifying critical-to-quality process parameters

  • The application of process-analytics from API production to drug product manufacturing to comply with quality requirements and tight external regulations

Adaptability of PAT to maximise patent life and get products to market faster through the ability of application at late stage process development


mes: world class manufacturing it

Transforming MES business by understanding the strategic improvements in eliminating paperwork and reducing time to market

  • Analysing the transparency on the manufacturing floor, increased flexibility and control gained through MES
  • Optimising your organisation whilst attaining the highest quality standards through every stage of the life


09:50-10:35

TBC by Vendor 


10:35-11:05
11:05-11:40
achieving manufacturing excellence

Using PAT and company vision towards operational excellence to reduce problems in data centralisation and management

  • Creating the optimum company environment to prepare for change and the strategic role played by industrial IT systems
  • A sound business model to support flexibility and ensure a robust knowledge base for deployment
  • Addressing the deep organisational changes and the need for top-down structure and communication across sites, cultures and countries 


mes: world class manufacturing it

The smooth placement of MES into current manufacturing systems to reduce economic, social and environmental impact

  • Preparing the knowledge base for implementation of MES to prevent calamity and failure to meet demand
  • Investigating the streamline processing of a core system to strategically understand the synergy required to reduce resistance 


11:40-12:25
keynote

Applying serialisation as a global programme and assessing the challenges of coordinating implementation with technology systems

  • Overcoming the complexities to distribution and manufacturing of  implementation of MES and automation processing and what this means for the serialisation timeline
  • Adopting a flexible approach to global serialisation deployment to prepare for cross-site coordination and reduce gray marketing   
  • The demand for high-speed printing through dust-and vibration-prone packaging lines makes printing and verification challenging 


12:25-13:25
solution meetings

13:25-14:10
14:10-14:55
keynote

Improvement in manufacturing through the implementation of continuous processes to meet and maintain quality standards

  • Sustaining high-performance and increased productivity through automating manufacturing processes
  • Increase in quality through reduced variation and a reduction in manual errors allowing for greater delivery of high standard products every time. 


14:55-15:25

Tea & Cake discussions on the key trends in drug manufacturing 


15:25-16:00
solution spotlight
achieving manufacturing excellence

Applying QbD and PAT to meet the critical requirement of sterility during the make and control manufacturing

  • Understanding the need for software providing data transparency and quality predictions rather than just supporting tools to properly implement QbD and PAT


solution spotlight
mes: world class manufacturing it

Creating a more user-centric access and process improvement initiatives to successfully implement QbD and MES

  • Leveraging system value to lower operating costs and speed up tech transfer from development to manufacturing
  • Increasing predictability of manufacturing output and quality to get faster regulatory approval 


16:00-17:15

Speakers Corner


17:15-18:00
keynote

The radical change of pharmaceutical manufacturing plants with the increasing use of sensors and remote access can boost global GDP by $15 trillion over the next two decades

  • Achieving real-time visibility, maintain equipment, ensure compliance and minimise waste though connecting manufacturing to IoT technologies
  • Linking intelligent product identifiers such as 2D barcodes and RFID tags with monitoring and data collection tools in production to allow a more complete digital record of products
  • How to deal with emerging challenges in data privacy, integration, equipment diversity and the evolution of applications


18:00-18:15
18:15-19:15

Our speed networking drinks is designed to accelerate your business contacts. You will greet other attendees in a series of brief exchanges during this time. It’s a great opportunity to share your professional background and business goals.




DAY 2, 2 December 2014

07:50-08:00
08:00-09:00
09:00-09:10
09:10-09:55
keynote

Focussing on the idea of consistent digitalisation and the linking of all production units through cyber physical systems to control production in real-time

  • Enhancing productivity through the radical change of manufacturing processes with the increasing use of sensors, 3D printing and next-generation robots.
  • Increased use of carbon neutral technologies to become more energy efficient and increase financial attraction
  • Virtual industrialisation to pre-simulate and verify processes to map out any potential pitfalls before implementation 


09:55-10:30
achieving manufacturing excellence

Using real-time process monitoring concepts for CPV  to address undesired variability

  • Preparing for the challenges that occur with this shift from understanding the relationship between critical process parameters and critical quality attributes (CQAs)
  • Using real-time near infrared spectroscopy to measure CQAs and integrating process and quality data into multivariate models 


mes: world class manufacturing it

Understanding the importance of integrating new hardware and software with serialisation and ERP systems for the delivery of efficient anti-counterfeiting solutions

  • Identifying the requirements of a dedicated server and additional interface to communicate with MES and link the two systems
  • Addressing the need for serialisation line master systems in order to receive work order information from the upstream server


10:30-11:00

Meet the Speakers


11:00-11:35
achieving manufacturing excellence

Adjusting the principles accustomed to batch manufacturing to manage various forms of waste

  • Understanding the three major issues of waste – waiting, defects, and over processing
  • Identifying the root cause of waste using “straw models” and applying the appropriate methodology to address it


mes: world class manufacturing it

The paperless process of standardising, maintaining and creating MBRs using an electronic framework

  • Analysing how companies run a centralised and efficient validation approach and how MES is the solution to flexibility.
  • Moving towards the paperless system and the adaption of the manufacturing floor environment to real-time control and the synchronisation of operations 


11:35-12:10
solution spotlight
achieving manufacturing excellence

Revolutionising the approach of utilising lean principles and sophisticated technology to make a quantum leap in pharmaceutical manufacturing

  • Reducing cycle times, enhancing process reliability and quality across the entire manufacturing chain from drug substance to final product
  • Integrating upstream chemical steps and downstream solids processing into one continuous processing line to enhance efficiency
  • Slow but steady adoption so development is line with production processes to prevent early maturity implementation failure 


solution spotlight
mes: world class manufacturing it

Reaping the benefits of today’s IT technology to make the big leap to cloud and the benefits and drawbacks from one of pharma’s leading innovative companies

  • Reducing large up-front capital investments in infrastructure, faster IT application and deployment, cost reduction and reduced energy consumption through cloud computing
  • Promoting the development of other transformational technologies
  • Regulatory challenges and security concerns such as protection of intellectual property (IP), reliability, data integration will be highlighted as the potential drawback of going to the cloud. 


12:10-13:10
keynote

Effectively incorporating serialisation, quality, automation and technology systems into the supply chain with no negative repercussions using the 5 steps to success

  • Understanding the principles of strategy, fulfilment plan, process & organisation, technologies and continuous improvement to witness major improvements.  
  • Process re-engineering and conducting a full process review to ensure high data quality and realise maximum results
  • Standardising processes and establishing a common use of IT systems and technologies from warehouse managements systems to ERP platforms 


13:10-14:10
solution meetings

14:10-14:55
14:55-15:30
achieving manufacturing excellence

Projected increase of 25% by 2018 in the use of smart robots for medical devices and primary packaging manufacturing shows the need to get up to speed

  • A new generation of automation technology transforming manufacturing and increasing efficiency, product safety, reducing costs and time to market.
  • Increasing intelligence of industrial robots to enable a productivity leap for the beneficial change in cost structures, skills landscape and production sites.
  • Integrating humans and robots using sensored human-machine interfaces


mes: world class manufacturing it

Achieving greater transparency and facilitating collaboration through cloud-based solutions through the analysis of a successful pharma case

  • Integrating the bird’s eye view of all operations across the organisation allowing real-time information and complete visibility into demand cycles
  • Analysing how outsourcing of APIs has pushed for the need for effective process control and plant management 


15:30-16:15
keynote - lost lecture

Industry case study of how big analytics has helped solve over a million dollar vaccine manufacturing problem and how Hadoop® software is being adopted across the industry

  • Real-time analysis of data allowing you to stay ahead of your competitors through better forecasting of products
  • Becoming customer-driven through improving interactions with outside suppliers and comparing performance of data across multiple plants
  • Applying the lessons learnt to other product lines to optimise production of lifesaving products 


16:15-16:30