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32nd ANNUAL ISO 9000 & AUDITS WORLD CONFERENCE
The World’s Leading Conference on ISO 9000 & Audits
ABSTRACT 1

Disrupt Yourself: The Modern Quality Professional

Industry: All Industries, Career Development

Keywords: Disruption, Digital Transformation, Modern Quality Professional

Level: All Levels

LinkedIn: http://ca.linkedin.com/in/peteralouche

The playing field has fundamentally changed for the modern Quality professional. As part of our continuous improvement mantra, it is imperative that Quality professionals’ step back and reframe their current and future roles in organizations. To do so, we need to look outwards and have a better understanding of what is happening around us with respect to ever-changing customer expectations, our workplace, emerging technologies, industries we serve, and compliance. We need to continue to develop the skills and mindsets that will help us over the next 10 years so that we can enable the organizations we serve to be successful.

In this talk, Peter Alouche will discuss the changing landscape for the role of Quality professionals in organizations, the skills they need to develop, and provide real-world examples of how quality professionals and organizations are embracing digital transformation initiatives and disruptive technologies to support their future growth.


ABSTRACT 2

A New Hope: Modern Computerized Systems Validation

Industry: Software/IT, Healthcare, Food/Drug/Cosmetics

Keywords: Computerized Systems Validation, GAMP5, 21 cfr 11

Level: All Levels

LinkedIn: http://ca.linkedin.com/in/peteralouche

Due to regulatory requirements, life sciences organizations must overcome various barriers to adopt new technology and automated systems. As a result, the hurdles to transform can be overwhelming and block progress at larger scales as there is inherent resistance to change.

There is an overwhelming affinity to leverage paper-based and document-centric tools which exacerbates siloed ways of working across departments and business units globally.

How can we help life sciences become even more agile while maintaining compliance? This is necessary to help reduce costs and inefficiencies that exist in pharma.

Digital transformation can help make this change and set up life sciences organizations to be agile for the long haul. In this talk, Peter Alouche will discuss the challenges that life science organizations face when it comes to adopting new technology in IT, R&D, and manufacturing and how digital transformation can help embrace new ways of working that is scalable, adaptable, and resilient.


BIOGRAPHY

PETER-ELIAS ALOUCHE

Director, Product Management, Veeva Systems Inc., Winter Garden, FL, USA

Peter is a Director of Product Management at Veeva Systems focused on developing, commissioning, qualification, and validation cloud software as part of Veeva's Quality Suite. He has worked in a variety of industries ranging from the nuclear power generation and utility sectors to the manufacturing of industrial inkjet systems and injection molding systems.

He has primarily worked for small to medium-sized manufacturing companies in Engineering, Quality, New Product Development, Strategy, and Product Management capacities. Peter has been involved with addressing nonconformances from ISO9001 compliance audits, Nonconformance processes, Incoming Inspections, Internal Audits, Six Sigma Green Belt projects, Root Cause Analysis workshops, Kaizen events, FMEA workshops, Supplier Quality initiatives, ISO9001 compliance, medical device design control, and new Product Development initiatives.

He has a bachelor's degree in Mechatronics Engineering from the University of Toronto and an MBA specializing in Innovation and Entrepreneurship from the Rotman School of Management at the University of Toronto.

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