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36 Current events about the topic process technology
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Comprehensive Overview of FDA Regulatory Compliance for Medical Devices
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 ...
Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications
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 ...
Medical Devices - Developing Effective Post Market Surveillance and Complaint Handling Systems
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 ...
Sample Preparation and Particle Sizing
03-09-2013 - 03-09-2013
Take the advantage and learn more about the theoretical foundations and instrumental possibilities of sample preparation and particle size determination. Contents of the workshop Sample preparation via size-reduction and dividing - Introduction to sample preparation - presentation of various ...
Sample Preparation and Particle Sizing
05-09-2013 - 05-09-2013
Take the advantage and learn more about the theoretical foundations and instrumental possibilities of sample preparation and particle size determination. Contents of the workshop Sample preparation via size-reduction and dividing - Introduction to sample preparation - presentation of various ...
Fine Grinding and Dispersing - Basic Course
09-09-2013 - 09-09-2013
The course gives an overview about the physical phenomena of grinding and dispersing in stirred media mills, and shows how this knowledge can be used for the design and optimization of grinding and dispersing processes, such as milling. Moreover, the effect of important operating parameters ...
13th International Symposium on Comminution and Classification
09-09-2013 - 12-09-2013
The European Symposium on Comminution and Classification (ESCC) is initialized by the working party of Comminution and Classification from the EFCE (European Federation of Chemical Engineering) with its current chair Professor Dr.-Ing. Arno Kwade. In 2013, September 9th to 12th, this ...
Validation of Computer Systems
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 ...
Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries
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 ...
Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products
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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