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Feb
13

Pharmeet 13-14 February 2012.Barcelona.Spain.

Workshop |Barcelona , Barcelona , Spain
February 13, 2012 - February 14, 2012 | 0 people are attending

Pharmeet was established in 2008 being its target the organization of pharmaceuticals events.

Located in a modern office complex, 15 minutes driving from Madrid, Pharmeet is integrated in an important Spanish pharmaceutical group.

Organizer: 
Patricia Martinez contactevents@pharmeet.com
More information about Pharmeet 13-14 February 2012.Barcelona.Spain. »
Feb
29

Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained

Conference, Webinar, Workshop |online, Houston, USA
February 29, 2012 | 0 people are attending

Many citations by FDA and notified bodies include findings with respect to insufficient information in the Design History File, not following the procedures to make the device as established in the DMR, and incomplete or inaccurate production data of incoming,in-process and finished products. Is your company able to access all relevant documents detailing the design of your device? Is your DMR accurate and is it being followed? Can the operators access your DMR? Are you recording and documenting all your production and testing data and maintaining them in the DHR?

Organizer: 
Compliance2go
More information about Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained »
May
30

Preparing for FDA Inspection and Handling the Consequences

Conference, Webinar, Workshop |online, Houston, USA
May 31, 2012 | 0 people are attending

We will review the latest inspection statistics released from FDA, discuss how to prepare for an FDA Inspection, discuss how to repsond to an FDA Inspection and discuss the possible outcomes of an FDA Inspection that has resulted in significant findings and/or citations.

 

Why should you Attend :

 

Organizer: 
Compliance2go
More information about Preparing for FDA Inspection and Handling the Consequences »

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