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
Paul has over two decades of industry experience in pharmaceutical manufacturing and laboratory research settings, with expertise in process cleaning, cleaning validation and contamination control. He holds a bachelor’s degree in biological sciences.
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At STERIS Life Sciences, Paul provides global technical support through field consultations, site audits, training presentations and educational seminars. He also manages the Process and Cleaner Evaluation (PACE™) program and analytical testing laboratory, which simulate Customer cleaning processes and support analytical method development and validation.
Paul is experienced in managing cross functional projects related to process cleaning and critical environment operations, with direct experience in the biopharmaceutical and biomedical device industries. He is a frequent speaker at industry events and has published several articles and book chapters related to cleaning validation and contamination control. He is also 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 industry experience, with expertise in product portfolio management for Good Manufacturing Practices (GMP) and research washer and steam sterilization technologies. He holds a bachelor’s degree in business marketing.
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At STERIS Life Sciences, Olivier is responsible for developing long-term vision and strategy for several product lines, as well as the tactics required to implement that vision. He also oversees new product and market development, monitors evolving industry standards and regulations and provides product training to support company objectives.
Olivier is an active member of the International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drug Association (PDA). He has coauthored several articles featured in scientific publications and has spoken at industry events for ISPE, PDA and other associations.
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