30-05-2013  - 31-05-2013

This course discusses the FDA’s regulatory authority for approving medical devices prior to marketing and the compliance programs used in enforcing its authorities during the manufacture and post-marketing reporting systems. It also provides FDA strategies towards inspections of manufacturing ...

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10-06-2013  - 11-06-2013

The European Union (EU) provides an attractive marketplace for medical device distribution. Development of requirements harmonized across the 27 member states should make it a straightforward process to get products approved in each country - but is it? This course works through the ...

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13-06-2013  - 14-06-2013

As users and regulatory agencies are becoming less ‘tolerant’ of medical device failure, regulatory agencies are placing greater emphasis on post market surveillance as a way to improve risk management and protect public health. This course will review the regulatory expectations for post ...

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20-06-2013  - 21-06-2013

Content & Learning Objective The most common cell culture method to study cell behavior under different stimuli, is the Petri Dish or its variants in multi-well plates. These systems are easy to use and versatile but still suffer from large cell variability. Reducing cell variability and ...

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02-07-2013  - 05-07-2013

Content & Learning Objective Epigenetics is defined as the study of inherited changes in gene expression through cell division. The epigenetic code is hypothesized to be the combined effects of histone modifications and DNA methylation on gene expression. While the genetic code in an ...

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09-07-2013  - 12-07-2013

Content & Learning Objective Molecular biology focuses on the structure, biosynthesis and function of DNA and RNA on the molecular level and how these interact among themselves and with proteins. Molecular biology techniques are essential for modern biological and medical research and the ...

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23-07-2013  - 26-07-2013

Content & Learning Objective This course will teach you basic knowledge or improve your existing expertise, so that your everyday work with cell culture will become safer and more efficient. Most of the time, beginners in this field can only acquire the basic knowledge they need by ...

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16-09-2013  - 17-09-2013

This course focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations. The course targets deliverable document content and how to avoid rework and unnecessary expense through a proactive approach. The core ...

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17-09-2013  - 18-09-2013

The course explores the politics, psychology and all the technical aspects of auditing, including discussions of their logistics, tools, and frequency. The course evaluates the talents and personnel characteristics required of those who consistently perform thorough audits which yield optimal ...

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19-09-2013  - 20-09-2013

This course is designed to provide participants with an understanding of the parameters for regulatory compliance, successful approaches to compliance, and meeting the concerns of regulators. Attendees will leave with a comprehensive set of tools for preparing regulatory initiatives, coping ...

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