Workshop SPCON


Digital Data Convergence, regulatory audit support and the development of PAT and QbD

Presenter

Name:            Marc Vorderman

Company:     Spreitzenbarth Consultants

Title:               CCO

email:            marc.vorderman@spcon.de

website:        www.spcon.de

Presenter´s biography

Information Technology Professional since 1983. More than 25 years of experience in the process manufacturing industry (Pharma, food and chemicals). Various senior leadership positions at international operating Enterprise Software vendors.
Worked with Global manufacturing and healthcare companies in North America and the EMEA region (Europe Middle East & Africa).

Specialized in the deployment of business applications and Information (data). Information for the day to day operations and as a strategic problem-solving and decision-making instrument.

Business solutions; ERP solutions, Human resources, Customer relationship management, Supply Chain Management, Regulatory compliance solutions, Data Science.

Languages Dutch (native), Fluent in German and English.

Objectives 

For pharmaceutical and health-care companies the ultimate objective is the real-time release of products through the design and development of processes that can consistently ensure a predefined quality output.

Plantex is a digital technology platform and SaaS data science application allowing for a holistic approach to necessary and critical process and quality data.

Information taking into consideration all the relevant process and quality data from various data sources. Data related to people, production, processes, equipment, raw-materials, CRO’s, CMO’s and environment. Including performance attributes of equipment (calibration), in-process resources and processes ensuring constant product quality.plantex-pharma-visual

Plantex functions and features is a new approach for statistical analysis, method verification and method development. Plantex will also provide business management with advanced planning and modeling (forecast, optimization, predictive) tools.
Decision management support is a fully integrated feature using collaboration tools such as chat and decision boards, visual collaboration (video) and the backup of all decision data. These so-called decision snapshots can be used for regulatory audit support and retrieved for (future) reference and verification.

Plantex can drastically cut back the time necessary to understand and verify the critical process parameters and the effect on critical quality attributes. Plantex will speed-up the development of- or the continues improvement of an existing- Process Analytical Technology (PAT) system and/or Quality by Design (QbD) framework.

Session Learnings

Workshop attendees will learn how to transform complex data into actionable knowledge to create tangible and profitable business actions. Effectively utilizing these data and the same time gaining quick and real-time insight into important cross-function business and quality information.
We provide you with new perspectives that help you in making complex decisions in challenging situations combining problem-solving and decision-making strategies.

Company Introduction

logo spreitzenbarth consultantsSpreitzenbarth consultants a consulting and development company in the industrial environment. Specialised in Industry 4.0 projects and a longstanding company history of 20 years.

We provide businesses with new perspectives, helping them making complex decisions in challenging situations combining problem-solving and decision-making strategies.