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Webinar On-Demand Available

Case Study: Risk Management for Annex 1 Sterile Production EMS

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During the webinar, we will guide Quality Assurance, Quality Control and Plant Operations managers through a practical step-by-step process that will help apply Annex 1 “Manufacture of sterile medicinal products” of Volume 4 European Union GMP Guide, which was enforced in August 2023. The Quality Risk Management process mandated by the Quality-by-Design (QbD) systematic approach will be a key topic. Annex 1 introduced changes aimed at increasing the efficiency of processes in pharmaceutical manufacturing. To achieve this goal and meet FDA Pharmaceutical CGMPs for the 21st century, it is necessary to adopt the QbD approach from risk management onwards.

As part of the webinar, we will use an Environmental Monitoring System (EMS) as a simple example to demonstrate how to assess risk using a pioneering tool that defines the specific process model. This approach reduces time to market and ensures that the system remains in a validated state throughout its operational life span. We will also hold an interactive Q&A-session during the webinar.

In just 60 minutes you will:

  • Get a summary of what are the key updates of Annex 1 (2022 revision)
  • Learn how to comply with the rigorous Annex 1 requirements through a unique registered algorithm allowing for rapid assessment of the alert and action levels needed for mandatory reporting
  • Discover a structured and dynamic Quality Risk Management tool allowing to easily map production processes, streamline risk scenarios, design a CAPA Plan
  • Discover a standardized “Digital Engineered Solution” for EMS that can assist in achieving manufacturing efficiencies through data integrity and root cause analysis on CPP deviations

Watch webinar >

On Demand Webinar    |    60 minutes   |    Free

The Speakers

Diego Bompadre is the Sales Director of Rigel Life Sciences, a highly specialized company offering solutions for contamination control and services to the pharmaceutical, biotech, and healthcare industries. With over 20 years of relevant experience in clean rooms and controlled environments in aseptic pharmaceutical applications, has worked alongside companies with advanced continuous environmental monitoring systems such as viable, total particle, and microclimatic conditions.
He joined Rigel Life Sciences shortly after the founding in 2008 and has since successfully built strong end-customer’s relationships, working closely with them during the internal investigation and inspection stages by the global regulatory authority, assisting them in the development of compliant and cost-effective contamination control programs, thanks to a deep experience in trend analysis provided by the process monitoring system. He actively participated in developing and launching the innovative IEMS Next® monitoring system, which is currently in the patent phase. Mr. Diego Bompadre is also an active member of the PDA and an ISPE affiliate.

Gianni Ponzo is a Chemical Engineer Managing Director at PAT Way Solutions, an engineering company offering technological solutions and services to the pharmaceutical and biotechnology industries.

With over 20 years experiences in Automation, Sanitary Design, Validation, Quality Risk Management, Gianni gained his experience as a Process Engineer in Menarini Biotech, and then moved to Pall Corporation as Project Manager. He founded PAT Way Solutions in 2012 creating a strong end-customer relationships, working closely with them on complex greenfield projects. Gianni Ponzo is also an active member of the PDA and an ISPE affiliate.

Roberto Zerbi is the Global Business Development Manager of the Pharmaceutical segment for Watlow.
Roberto has spent more than 25 years at Eurotherm, covering various roles: project management, sales, marketing, 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 a member of the Alumni of the Politecnico di Milano and of the International Society for Pharmaceutical Engineering (ISPE).

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