Validation per ISO 11137 requirements
1.5-day training session | In-Person Training
Cleaning is often a critical step in the manufacturing process of single-use medical devices as contaminants could cause serious safety problems as well as impact device biocompatibility and sterilization effectiveness. It is the responsibility of the medical device manufacturer to ensure physical, chemical and microbiological contaminants (as applicable) are reduced to a safe level and to provide objective evidence of the verification of the cleaning process effectiveness.
Implementing an effective cleaning process on medical devices requires knowledge on the cleaning technologies available, process design, risk management, test methods, cleanliness requirements, process validation, and process verification. These topics will be covered in this comprehensive course with a focus on NF ISO 19227:2018.
REQUIRED LEVEL
Some familiarity with process validation (such as OQ/PQs) and general knowledge of medical devices manufacturing.
Charlotte Negrón-Morales Product Reviewer, GMED North America
Charlotte is a Product Reviewer at GMED North America. She carries out evaluations as part of the CE marking conformity assessment in the field of medical devices with focus on topics related to sterilization, packaging, and cleaning.
She has a technical background in Chemistry & Engineering. She worked in the Orthopedics Medical Device industry for 7 years in manufacturing, R&D and Quality Department as a Cleaning Validation Engineer, Packaging Development Engineer, and Sterilization Engineer; among other roles. Over the course of these years, she developed a unique set of experiences within the medical device regulatory and quality science topics.
Charlotte currently works at GMED NA as a product reviewer and provides regulatory support for the transition to the European Regulation EU 2017/745.
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