Aizon

Prepare to go beyond GMP to improve corporate data culture and knowledge management in a proactive, not reactive, oversight perspective.

https://globalmeet.webcasts.com/starthere.jsp?ei=1589587&tp_key=f458f87a53

In a highly regulated industry such as pharmaceuticals each company needs to prove the quality of their products by showing data produced during their production processes. Management of records and data by these regulated companies is controlled by data governance, which embraces people, processes, and the technology required for effective data handling. All this leads directly into the production of high-quality drug product. Keeping up with requirements is obviously a vital step, but more generally, prioritizing how to actively demonstrate what controls you have in place to prove trust in the data in your organization, every data lifecycle step, the GxP (IT and non-IT) systems, and all related processes, makes a vital difference in how regulators see your quality management maturity (QMM) but also how both staff and clients see the company itself.


 how to help set controls in your organizations over data, and why efforts spent here are financially rewarding in the long run.

Understand how data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees

Learn how to do better to manage Data integration within your organization, and how to seamlessly deliver this data to outside partners and also regulators

Pharmaceutical Regulatory Science
Team (PRST) at TU Dublin and
Director and MMD Knowledge
Management Center of Excellence
Merck & Co Inc.

 is a member of the Pharmaceutical Regulatory Science Team (PRST) at TU Dublin, as well as Director in the MMD Knowledge Management Center of Excellence at Merck & Co Inc. Paige brings over 30 years’ experience working in a regulated environments (including Pfizer, Wyeth, Genetics Institute, Monsanto and USDA/USCS), and has been responsible for developing and implementing KM programs, quality systems for GLP, GCP, and GMP, electronic records/electronic signatures programs, and automation validation methodologies.


European Laboratory Compliance
Specialist
Agilent Technologies

 is European Laboratory Compliance Specialist at Agilent Technologies. Garry has 25 years of experience working within regulated pharmaceutical environments and providing compliance guidance to regulated companies across Europe.




Webcasts

Webinar Date/Time: Thursday February 24, 2023 at 11am EST | 10am CST | 8am PST


Unpacking the Science Behind Data Integrity

Pharmaceutical manufacturers are facing decreasing margins and need to identify new ways to increase yield, quality and efficiency through increased visibility into their operations and better understand their processes. Join this webinar to learn how advanced technologies enable manufacturers to continuously determine, in real time, actionable insights and act quickly on them in order to meet current and future market demands

Pharmaceutical manufacturers are under increasing pressure to fast-track technological innovation to improve their manufacturing operations. In order to adapt to new approaches like ‘Industry 4.0’ and continuous manufacturing, combat growing and intense competition, and keep up with the increasing demand for personalized medicine and therapies, organizations are seeking to identify areas where technology can make the most impact.
In this webinar, attendees will hear from three experts on the following topics:

Benefits of Pharma 4.0 and Enabling Technologies like AI and ML

Practical use cases in achieving compliance using AI in Pharma manufacturing

Real world reflections on Manufacturing Intelligence

How advanced technologies, such as artificial intelligence and machine learning, will deliver the ability to seamlessly and efficiently capture and monitor disparate data from across the organization.

Initial steps to reaching operational intelligence in a GxP compliant manner with end-to-end data integrity

How adopting these technologies results in pertinent benefits, such as decreased downtime and increased productivity

Site leads/head of site, compliance, quality, digital transformation, technology, operations


LifeBee partner and Director for the Industrial Operations area
LifeBee
Digitalizing Life Sciences

is a LifeBee partner and Director for the Industrial Operations area. Graduated in Computer Engineering at Politecnico di Milano in 1994. He has over 25 years of experience in Consulting and in the management and implementation of System Integration software projects and Consulting for Production, Maintenance, Quality in the "regulated" Life Science field. He started his career in 1996 in Atos Origin as a Consultant in the Life Science sector within the Health Care Unit working with leading Italian and international pharmaceutical companies.
In 2004 he was among the founders of LifeBee, Italian consulting firm which has now 75+ clients and 1000+ projects in Life Science.
Since 2016 Graffeo led the Serialization anc Track&Trace Business Unit for the company reaching over 30+ clients and 100+ projects in this field.




CEO, CTO, Co-Founder
Aizon

Pep GubauCEO, CTO, Co-FounderAizon


 is the CEO, CTO, and founder of Aizon and has been a tech entrepreneur for the last 30 years. Since Aizon's inception in 2013, Pep has been responsible for the company’s product vision and technology strategy, shaping the company’s mission of transforming the Pharma and Biotech Manufacturing Industry using Aizon’s innovative technologies.

Pep is an economist with an engineering background and holds several international patents related to the encryption, transmission, storage and processing of data for regulated environments in the cloud. Pep loves detecting opportunities, understanding challenges, imagining and building solutions, envisioning the future, and creating and growing Tech companies from scratch.




Strategic Advisory Board member
Aizon; VP and CIO of Manufacturing IT
Merck (retired)

An Information Technology professional for more than 30 years, 

 is most recently Vice President and CIO of Manufacturing IT at Merck. In this role, she provided strategic leadership, oversight and delivery of information technology and digital solutions for the Merck Manufacturing Division. A change agent with proven track-record of delivering high-impact projects producing outstanding business results broadly across Pharmaceutical Supply Chain and Manufacturing, Michele and her team have been nationally recognized for the past 7 years in the areas of technical innovation, including next generation data and analytics platforms; supply chain transformation; and resiliency /modernization/digitization in manufacturing plants. In Nov 2017, Michele was awarded a Gold Stevie® Award for Women in Business in the Life Sciences and Healthcare Transformation category. Michele was named to Bold’s Business Top 20 of Chief Information Officers for 2019. She currently runs her own consultancy business, providing advisory services with an emphasis on IT Transformation and Women in STEM.

Webinar Date/Time: Tue, Dec 13, 2022 9:00 AM EST


How AI and Advanced Analytics can Support Process Excellence and Compliance Within Pharma   Manufacturing

Articles

This white paper highlights Pharma’s data integrity challenge and its impact on manufacturing, and proposes solutions for Pharma’s successful digital transformation journey.

Life Sciences’ Data Integrity Challenge

Aizon delivers AI-based insights into nearly every portion of the pharma and biotech manufacturing process, all while helping CDMOs meet compliance standards. Our AI identifies potential optimizations that can boost yield and cleanly displays them in the dashboard. Prebuilt analytics tools enable CDMOs and customers to analyze production data, while data models identify and alert potential risks, helping better ensure product quality.

Providing CDMOs Transparency and Control for the Competitive Edge 