This course provides an exploration of software validation principles within the context of medical device manufacturing.
Duration: 16 hours
Modality: Group
Participant limit: 15
Learn about the correct methods validation that can help the organization to minimize risk which could be associated to over-rejection or worst shipping product that is defective to customer.
Duration: 12 hours
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
Modality: Group
Participant limit: 15
Learn about the change control process, the interaction with different elements of the quality system, and the considerations when creating a process change assessment.
Duration: 12 hours
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
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
Modality: Group
Participant limit: 15
Learn about the 8D Methodology for Root Cause Analysis / Structured Problem Solving.
Duration: 8 hours
Modality: Group
Participant limit: 15
The objective of this course is to provide students with the knowledge and skills needed to excel in the critical area of effective writing for change controls within the medical devices industry.
Duration: 12 hours
Modality: Group
Participant limit: 15