Watlow® to host Annex 1 Risk Management Webinar

St. Louis, Missouri, USA: – World-leading advanced thermal management solutions provider Watlow® will sponsor and co-host a webinar on Risk Management for GMP Annex 1 Sterile Production featuring a case study Environmental Management System (EMS).

The hour-long webinar is being hosted on the CPHI Online platform and will take place starting 1600 hrs. CET (1000 hrs. EST) on February 28, 2024. Registration is free of charge and available online (see Resources).

Need for Annex 1 solutions

The webinar is a response to the European Union (EU) updating of the Annex 1 Volume 4 “Manufacture of sterile medicinal products” GMP Guidelines that came into force from August 2023.

It will offer a step-by-step guide to creating a Quality Risk Management process that complies with the Quality-by-Design (QbD) systematic approach mandated by the Annex 1 revisions, which are aimed at increasing the efficiency of processes in pharmaceutical manufacturing. Similar measures will be needed to comply with emerging FDA Pharmaceutical GMP standards.

The session is aimed at Quality Assurance, Quality Control and Plant Operations managers who need guidance on adopting QbD methodologies, including risk management, to create Annex 1 Vol 4 compliant manufacturing environments.

EMS Case Study

To this end, the webinar will illustrate a case study of how to set up an Environmental Monitoring System (EMS) to assess risk using a pioneering tool that defines a specific process model. This structured and dynamic QRM tool will allow plants to map production processes, streamline risk scenarios, and design a CAPA Plan. Overall, these measures will reduce time to market and ensure that the production system remains in a validated state throughout its operational life span.

The session will also summarise the key updates of Annex 1 2022 revisions and their implications and present a compliance solution powered by a unique registered algorithm allowing for rapid assessment of the alert and action levels needed for mandatory reporting.

By the end of the webinar, the audience will have discovered a structured and standardized “Digital Engineered Solution” for EMS that can assist in achieving manufacturing efficiencies through data integrity and root cause analysis on CPP deviations

The webinar will conclude with an interactive Q&A-session.

Expert speakers

The seminar will be presented by three experts in the field of Environmental Management Systems:

• Diego Bompadre is Sales Director of Rigel Life Sciences, offering specialized solutions for contamination control and services to the pharmaceutical, biotech, and healthcare industries. He has actively participated in developing and launching Rigel’s innovative IEMS Next® monitoring system, which is currently in the patent phase. With more than 20 years of relevant experience in clean rooms and controlled environments in aseptic pharmaceutical applications, Diego Bompadre has worked alongside companies with advanced continuous environmental monitoring systems such as viable, total particle, and microclimatic conditions. He is a prominent member of the PDA and an affiliate of the International Society of Pharmaceutical Engineers (ISPE).
• Gianni Ponzo is Chemical Engineer Managing Director at PAT Way Solutions, an engineering company that he co-founded in 2012 to offer technological solutions and services to the pharmaceutical and biotechnology industries. Mr., Ponzo has more than two decades of experiences in Automation, Sanitary Design, Validation, Quality Risk Management, starting as a Process Engineer in Menarini Biotech, and then moving in Pall Corporation as Project Manager. He Gianni Ponzo is also an active member of the PDA and an ISPE affiliate.
• Roberto Zerbi is Director and Global Business Development Manager at Watlow Life Sciences with more than 25 years’ experience at its recently acquired affiliate Eurotherm, where he has covered various roles including project management, nurturing partnerships with OEM machine builders, strategy, and digital innovation. His experience ranges from continuous to batch processes, covering the life cycle from detailed design to predictive maintenance. In recent years Roberto has been involved in digital transformation, the impact of innovation on business processes, Quality by Design, and risk management. He is passionate about robotics, artificial intelligence, and cognitive processes. Roberto is an alumnus of the Politecnico di Milano and a member of the ISPE.

About Watlow

Watlow is a global industrial technology company that uses its world-class engineering expertise, advanced thermal systems and manufacturing excellence to enrich everyday life.

Many of the world’s leading companies leverage Watlow’s technologies in vital applications such as semiconductor processing, environmentally friendly energy solutions and lifesaving medical and clinical equipment, to name a few.

Founded in 1922, Watlow’s culture is driven by its mission of “Enriching Lives Through Inspired Innovation,” enabling the company to deliver high-impact solutions that improve its customers’ competitive advantage.

Learn more at: https://www.watlow.com

Resources

Click on to Case Study: Risk Management for Annex 1 Sterile Production EMS to register for the free webinar.
Click on Annex 1 Updates Summary for further information.
Click on Digital EMS Solution to learn more.