Practical Solutions in CSV and SDLC for GXP & MedDev

Join us on the 3.10.2018 in London, UK

Join us for this special knowledge sharing and networking one-day conference on practical solutions in Computer System Validation (CSV) and Software Development Life Cycles (SDLC) designed especially for pharma and life science professionals who specialize in quality systems, regulatory compliance, IT and software development.

In an age when computerised systems are dividing lines between winning and losing, you need to find ways to continuously and relentlessly innovate. Compliance is no longer enough; you need a validation framework to help your business move quicker and release more often.

At the conference, industry experts will explore the newest trends in computer system validation (CSV), share insights on standards and guidelines for setting up a CSV framework, and relate their experiences with the best available technologies and tools to effectively reduce the burden of CSV.

You'll have the opportunity to participate in presentations focused on CSV in GXP (GMP, GLP, GDP, GVP, GCP) or medical devices (MedDev) environments, where compliance regulations like 21 CFR Part 211, Part 820, Part 11 or EMA EudraLex Vol. 4 – Annex 11 are mandatory.

By the end of the conference, you'll have a full arsenal of practical knowledge and invaluable insight that adds value to your quality management system and organisation overall.




The Capability Maturity Model Integration (CMMI) and a framework for agile software (Scrum) for GMP products and supplier audits

Stellan will present how Wolfram Ott & Partner transformed a cumbersome, wasteful paper-based quality system to be sleek and efficient using two key ingredients:

  • the CMMI Model (Capability Maturity Model Integration) as the guideline for the quality processes;
  • Microsoft team foundation server as the electronic platform for project work.

The journey took nearly six years to complete, and consequently caused a positive shift in company culture. As a supplier to pharmaceutical companies, the company is frequently audited. Today, thanks to the new system and its significant compliance improvements, Wolfram Ott & Partner routinely passes with flying colors.

Stellan Ott

CEO at Wolfram Ott & Partner GmbH

Using Jira and Confluence as e-QMS

JIRA and Confluence have become the operational backbone for many teams, especially in software development. The possibility to configure the tools to support virtually any business process tempts many organizations to use these platforms for their QMS.

Rina will showcase real life examples of QMS processes in Jira and Confluence. The presentation will also explore the essential ingredients for a successful project and explain how transitioning to a digital QMS platform should be managed to ensure high return on investment and long-term benefits.

Rina Nir

CEO at RadBee Ltd.

Computer System Validation (CSV) for Jira and Confluence: a sensible and compliant approach

Improving the classical DQ/IQ/OQ/PQ V-model approach to paper-based records is crucial to realizing digitalization projects throughout your organization and ensuring your company is fit for the future. The management of real business processes including changes, thousands of requirements, iterative test runs over frequent releases, multiple test environments, development orders and task tracking, incident management and bug fixing – not to mention the need for close collaboration and communication across teams – is literally impossible using only software from MS Office Suite (Word, Outlook, Excel).

Stop feeding the resource monster the reams of paper it thrives on, and reclaim your systems… and sanity. Markus’ presentation will provide you with practicable examples following the ISPE GAMP 5 approach for any GXP compliance project – turning traditional thinking on validation to eValidation.

Markus Roemer

Chief consultant and founder of Comes Compliance Services, Ambassador ISPE DACH

Data Integrity: a practical perspective 

Dive into real-world data to discover what you can and should do to up your data integrity game and improve all your KPIs, especially compliance. Keith will discuss examples from manufacturing and labs, illuminating the differences in requirements of data integrity between GMP and GLP environments and giving you concrete examples of how you can apply these critical insights to your organization.

Keith Williams

Former member of ISPE GAMP European Committee, Principal Consultant, C3 Limited

Software Development Life Cycle (SDLC) management: marrying DevOps principles with a compliant software release

As one of the biggest trends in operational excellence, DevOps promises significant gains. These are achieved through organizational changes and extensive use of modern digital tools. Rina will discuss:

  • Why the DevOps philosophy is so well aligned with quality management and compliance
  • How a DevOps approach can also deliver a regulated and compliant software release
  • Demonstrate how a digital release cycle may be implemented
  • Why this matters
Rina Nir

CEO at RadBee Ltd.

Regulatory landscape updates and the urgency of digitalization

Laurence will touch on several developments in medical device regulations. Some of these include integration of post-market surveillance with an ISO-14971 compliant risk management system, consideration of device identification, classification and clinical evaluation, and the impact of the FDA strategic priorities through 2020.

Non-product software validation has also undergone a significant evolution. Siemens has been actively involved in a working group with industry and FDA leaders to clarify FDA intent in validation of software tools. This work will be reflected in a new FDA guidance document to be released around Q4 2018.

Coincidentally, non-product software validation activities have much to offer, similar to production equipment validation. Some consideration will also be given to how design specifications can be shared in the form of critical to quality characteristics. The closed-loop production equipment validation process is then enabled, affording equipment impact analysis simple traceability.

Laurence Sampson

Sr Director Medical & Lifescience, Industry Strategy, Siemens Product Lifecycle Management Software Inc.

Use case demo: Requirements management concepts and how Polarion is used to drive a more effective development approach

Carl will share his experience in designing a medical device, and prepering for regulatoory submission, usins Polarion as the digital platform.

Carl Pullen

Senior Consultant Mechanical Engineer – Technical Project leader,

Medical device development and Quality Systems expert.

Cambridge Design Partnership

Proactive quality risk management

Growth, digitalization, patient-centricity: The Life Science industry is experiencing serious pressure and rapid change. Many companies find regulatory compliance a major obstacle on their path to success. They ask serious questions about their compliance:

  • Are we overspending on time and resources, hampering efficiency and our bottom line?
  • Are we underspending, running the risk of out-of-control compliance?

Klavs will explore concrete ways to make the black box of compliance more transparent throughout the entire organization. The business result: predict the impact of new initiatives, new regulations, and new technology on your quality efforts. And keep your efforts optimized – efficient and in control.

He’ll also discuss a preview of the results of Epista’s 2018 Life Science Compliance Maturity Survey. Their 2017 study focused on Denmark and exposed many interesting industry challenges. This year, Epista Life Science is focusing on the entire Nordic region and will share a preview with our group.

Klavs Esbjerg 

CEO and Founder, Epista Life Science


  • 09:00-09:30 Registration and coffee
  • 09:30-09:40 Welcome, Rina Nir
  • 09:40-10:30 The Capability Maturity Model Integration (CMMI) and a framework for agile software (Scrum) for GMP products and supplier audits,  Stellan Ott
  • 10:30-11:15 Using JIRA and Confluence as e-QMS, Rina Nir
  • 11:15-11:30 Coffee break
  • 11:30-12:15 Computer System Validation (CSV) for Jira and Confluence: a sensible and compliant approach,  Markus Roemer
  • 12:15-13:00 Regulatory landscape updates and the urgency of digitalization,  Laurence Sampson
  • 13:00-13:15 Use case demo: Requirements management concepts and how Polarion is used to drive a more effective development approach, Carl Pullen
  • 13:15-14:00 Lunch
  • 14:00-14:45 Data Integrity: a practical perspective that takes a deep dive into real-world data, including examples from GMP,  Keith Williams
  • 14:45-15:30 Software Development Life Cycle (SDLC) management: marrying DevOps principles with a compliant software release, Rina Nir
  • 15:30-16:00 Coffee break
  • 16:00-16:45 Proactive Quality Risk Managment,  Klavs Esbjerg
  • 16:45-17:00 Closing remarks
  • 17:00-18:00 Happy hour networking reception

Join us on the 3.10.2018 in London, UK

Practical Solutions in CSV and SDLC for GXP & MedDev