Upcoming Seminars

April 23rd and 24th, 2015
Zurich, Switzerland

David R. Dills
Complaint-Handling, MDR and Recall Management

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.


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. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability.


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. During the first six months, they attend extensive classroom and hands on training.


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.



Partial Client List

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