Upcoming Seminars

April 28th & 29th, 2015
Zurich, Switzerland

Dr. Ludwig Huber
Validation and Part 11/Annex 11 Compliance of Computerized Analytical Systems and Data

Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use.


May 7th & 8th, 2015
New Orleans, LA

Casper Uldriks
FDA Inspections: Before, During and After

FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one.


May 14th & 15th, 2015

David Dills
The A to Z's of Writing and Enforcing Effective SOPs (Standard Operating Procedures)

Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story.


May 21st & 22nd, 2015
Boston, MA

Dev Raheja
How to Conduct Medical Device Risk Analysis Effectively

Why companies are prone to having past problems in new devices? One of the main reasons seems to be the "weak cognition." It is usually the result of short term memory, inattention to details, insufficient vigilance,



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