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Complete medical device manufacturing visibility and control for combination and hybrid products

Track: Manufacturing Operations User Connection

Session Number: 170573
Date: Wed, May 10th, 2017
Time: 1:30 PM - 2:15 PM
Room: 208

Description:

The Medical Device industry is unique in that it represents nearly every type of product and manufacturing process – including the discrete assembly of an MRI machine, the injection molding of blood filters, the machining of medical screws, the rolled processing of blood glucose test strips, and the 3D printing of knee joints.  Medical Device manufacturers must deal with the complexities associated with this variety of processes and products while staying compliant with the regulations of the FDA in the United States and other regulatory bodies around the world.

Combination and hybrid products, such as a cardiac drug eluding stent, pose particular challenges due to the fact that they combine both batch (wet) and discrete manufacturing processes and must comply with both Medical Device and Pharmaceutical regulations.  This session will discuss those challenges and the capabilities of the Camstar Batch Processing module to provide complete manufacturing visibility, control and compliance.

Session Type: Interactive Lecture

Related Industry: Medical Devices & Pharmaceuticals
Learning Objectives: 1. Understanding the complexities of Medical Device & Diagnostics manufacturing in general and combination/hybrid products in particular
2. Gaining insights into the benefits of an eDHR/eBR system for manufacturing visibility, tracking and control
3. Understanding the capabilities of the Camstar Batch Processing module
Applicable Software: Camstar
Session Type: Interactive Lecture

Related Industry: Medical Devices & Pharmaceuticals
Learning Objectives: 1. Understanding the complexities of Medical Device & Diagnostics manufacturing in general and combination/hybrid products in particular
2. Gaining insights into the benefits of an eDHR/eBR system for manufacturing visibility, tracking and control
3. Understanding the capabilities of the Camstar Batch Processing module
Applicable Software: Camstar