Date: 8 June, 2023
Time: 17:00 - 18:00 PM CEST | 11AM - 12 PM EST | 8:00 - 9:00 AM PST
Medical device manufacturing requires various levels of skilled operators. Successful and efficient training programs, compliant with ISO 13485:2016, utilize a risk-based approach to implement and verify effectiveness of training, yet many training programs fail to incorporate ongoing monitoring of the training program’s effectiveness. This is critical when it comes to lowering the risk of manufacturing activities including assembly, in-process testing, including quality control activities such as inspection and release of product, etc. Various training methods are commonly deployed such as read and understand and on-the-job training, while the associated methods commonly used to measure effectiveness are quizzes and trainer approval of on-the-job training completion of given activities, respectively. Although these training effectiveness measurements can be effective, their level of effectiveness is likely unknown without routine monitoring. We will discuss ways to track and trend effectiveness of the training program used within a manufacturing site. In addition, we will discuss methods to evaluate training to verify implementation effectiveness.
This webinar will be co-hosted by Patricia Santos-Serrao, RAC MasterControl Senior Director of Product Management.
Upon completion of this session, participants should be able to:
Identify three (3) common types of training used in the medical device manufacturing environment.
- Determine metrics for monitoring training effectiveness.
- Determine the appropriate training methods and measure of effectiveness methods to use in a risk-based manner for staff within a medical device manufacturing site (including supporting staff such as HR, Quality Technicians, R/D Associates, Regulatory, Clinical, Logistics).
- How to assess what training is needed based on competence from education, experience and skills.
Patricia Santos-Serrao is a life sciences professional with over two decades of experience in quality, regulatory, and clinical business processes for the pharmaceutical and biotech industries. She worked for several Tier 1 pharmaceutical companies, including Schering-Plough and Boehringer Ingelheim, prior to transitioning to various technology solutions and services providers for life sciences.Patricia is a member of Regulatory Affairs Professional Society (RAPS) and has earned her Regulatory Affairs Certification (RAC) from RAPS and the Regulatory Affairs Certification Board (RACB). She is also a member of the Drug Information Association (DIA). She currently holds a position as the product management director at MasterControl, working with development, product management, sales, marketing, and services to develop solutions designed for the pharmaceutical industry with a focus on solutions for clinical research regulatory affairs, quality, and compliance. Prior to joining MasterControl, she held positions as a product manager and a business process analyst in companies such as QUMAS, CSC, Liquent and CDC Solutions.
MasterControl is a leading provider of cloud-based quality and manufacturing software for life sciences and other regulated industries. For three decades, our mission has been the same as that of our customers – to bring life-changing products to more people sooner. MasterControl helps organizations digitize, automate, and connect quality and manufacturing processes. Innovative MasterControl tools have a proven track record of improving product quality, reducing cost, and accelerating time to market. Over 1,100 companies worldwide use MasterControl solutions to streamline operations, maintain compliance, easily analyze, and interpret large amounts of data, and visualize business insights in real time. For more information, visit www.mastercontrol.com.
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