Annex 1 webinar now available on demand

St. Louis, Missouri, USA: – World-leading advanced thermal management solutions provider Watlow® has now made its webinar detailing a QbD approach to EU’s GMP Annex 1 compliance available on demand.

The free-to-view webinar Case Study: Risk Management for Annex 1 Sterile Production EMS guides 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 came into force in mid-2023.

QbD approach to risk management

The hour-long webinar can be viewed on the CPHI Online platform following registration (see Resources). It sets out a Quality Risk Management process to meet the Annex 1 requirements for a Quality-by-Design (QbD) systematic approach to pharmaceutical manufacturing processes that applies from risk management onwards. This approach will also be necessary to ensure FDA GMP compliance.

Originally hosted in February 2024, the webinar summarizes the key updates of Annex 1 2022 revisions and their implications and presents a compliance solution powered by a unique registered algorithm allowing for rapid assessment of the alert and action levels needed for mandatory reporting. It also included a Question & Answer session.

EMS Case Study

The webinar illustrates a case study of how to set up an Environmental Monitoring System (EMS) to assess risk using the pioneering QRM tool to define a specific process model. This structured and dynamic approach allows plant managers to map production processes, streamline risk scenarios, and design a corrective and preventative CAPA Plan.

Overall, the webinar presents 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 to reduce time to market and ensure that the production system remains in a validated state.

Expert presenters

The discussion is led by three experts in the field of Environmental Management Systems who are all affiliate members of the International Society of Pharmaceutical Engineers (ISPE):

• Sales Director of Rigel Life Sciences Diego Bompadre has actively participated in developing and launching Rigel’s innovative IEMS Next® monitoring system. 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.
• Chemical Engineer Managing Director at PAT Way Solutions Gianni Ponzo co-founded the engineering company in 2012 to offer technological solutions and services to the pharmaceutical and biotechnology industries. Mr. Ponzo has more than two decades of experience in Automation, Sanitary Design, Validation, Quality Risk Management. Like Mr. Compadre, he is an active member of the Parenteral Drug Association (PDA).
• Director and Global Business Development Manager at Watlow® Life Sciences Roberto Zerbi has 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.

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 view the webinar on CPHI (registration required).
Click on Annex 1 Updates Summary for further information.
Click on Digital EMS Solution to learn more.