This course provides an exploration of software validation principles within the context of medical device manufacturing.
Duration: 16 hours
CEUs: 1.7
Modality: Group
Participant limit: 15
This course seeks to provide the student with the tools and learning of the 8D methodology for problem solving and its application through different exercises developed during the class. This methodology includes the following elements:
Learn about the 8D Methodology for Root Cause Analysis / Structured Problem Solving.
Duration: 8 hours
CEUs: 0.9
Modality: Group
Participant limit: 15
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Learn about the 8D Methodology for Root Cause Analysis / Structured Problem Solving.
Duration: 8 hours
CEUs: 0.9
Modality: Group
Participant limit: 15
This course provides an exploration of software validation principles within the context of medical device manufacturing.
Duration: 16 hours
CEUs: 1.7
Modality: Group
Participant limit: 15
Packaging Fundamentals provides an overview of essential concepts related to packaging in the context of medical devices. It covers the applicable standards and regulatory requirements, an exploration of packaging materials and key topics.
Duration: 16 hours
CEUs: 1.7
Modality: Group
Participant limit: 15
The primary goal of this course is to provide the student with the tools and learning of the DMAIC methodology as a process improvement approach. Students will also learn about various tools that help assess and enhance the quality of processes.
Duration: 9 hours
CEUs: 1.0
Modality: Group
Participant limit: 15
Learn the entire process validation cycle and the key elements such as VMP, EQ, OQ and PQ, and the correlation with the regulations and standards
Duration: 24 hours
CEUs: 2.5
Modality: Group
Participant limit: 15
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