Navigating Annex 1: Understanding Compliant Cleaning and Validation for Product Contact Equipment
An effective contamination control strategy (CCS) is essential to operate successfully under EU GMP Annex 1 guidelines. A well designed CCS, supported by validated washers and cleaners, is critical to ensure consistent, reliable outcomes while protecting product quality and patient safety.
Join our complimentary webinar to learn how to implement a risk-based CCS, allowing you to define critical control points and evaluate the effectiveness of control and monitoring measures in the cleaning process. Additionally, explore how automated washing and cleaning chemistries support compliant cleaning validation across process design, qualification and continued verification.
If you have previously attended our Annex 1 webinar series, we encourage you to join us again as we revisit current trending topics!
*Please note that the webinar broadcast time is listed in the Eastern Time Zone (ET). If necessary, be sure to convert to your local time zone.
Meet the Presenters
Paul Lopolito
With over two decades of industry experience in pharmaceutical manufacturing and laboratory research settings, Paul provides global technical support for process cleaning, cleaning validation and contamination control, which includes field support, site audits, training presentations and educational seminars.
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He holds a bachelor’s degree in biological sciences.
Prior to joining STERIS Life Sciences, Paul spent three years as a Manufacturing Technical Services Manager at Massachusetts Biological Laboratories providing technical support and project management for the vaccine, monoclonal antibody, blood product and filling/packaging groups. He also spent time at TEI Biosciences, where he held positions of Research Associate, Laboratory Manager and Manufacturing Manager.
Paul manages the Process and Cleaner Evaluation (PACE™) program and analytical testing laboratory for STERIS Life Sciences, which simulates a Customer’s cleaning process to make recommendations for improvements and analytical method development and validation. He has expertise in managing cross-functional projects related to process cleaning and critical environment operation with direct experience in the biopharmaceutical and biomedical device industries.
Paul is a frequent speaker at industry events and has published several articles and book chapters related to cleaning validation and contamination control. He is an active member of the International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drug Association (PDA).
Olivier Van Houtte
Olivier has over a decade of experience managing the STERIS Life Sciences portfolio of products for Good Manufacturing Practices (GMP) and research washer and steam sterilization technology. He holds a bachelor’s degree in business-marketing.
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At STERIS Life Sciences, Olivier is responsible for developing a long-term vision for several product lines and the strategies and tactics to implement that vision. He is also responsible for new product and market development, understanding the latest industry standards and regulations and providing product training to achieve company objectives.
He is an active member of the International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drug Association (PDA). Olivier has co-authored several articles that have been featured in scientific publications. He has also spoken at industry events for the ISPE, PDA and other associations.
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