GMP NEWS 2009

30.09.2009

Personal Liability of the Qualified Person and Possibilities for Insurance

Discussions of a QP's liabilty and possibilties for insurance can be heard everywhere. Read more about the things that need to be considered.

More Personal Liability of the Qualified Person and Possibilities for Insurance

26.08.2009

FDA limits Timeframe for Responding to a 483

In a new programme starting on 15 September 2009, the FDA intends to set the timeframe for statements and responses to a 483 to a maximum of 15 business days. Read more about the new programme.

More FDA limits Timeframe for Responding to a 483

14.05.2009

EMEA Publishes Guideline on Replacement of Rabbit Pyrogen Testing

The European Medicinces Agency (EMEA) has published a new Guideline on Replacement of the Rabbit Pyrogen Testing by an Alternative Testing for Plasma derived Medicinal Products to provide a possibility to cover detection gaps like fever inducing cytokines. Read more here.

More EMEA Publishes Guideline on Replacement of Rabbit Pyrogen Testing

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GMP NEWS 2009

Personal Liability of the Qualified Person and Possibilities for Insurance

FDA limits Timeframe for Responding to a 483

EMEA Publishes Guideline on Replacement of Rabbit Pyrogen Testing

Recommended Event

GMP-Auditor Practice An advanced Auditor Course with many interactive Sessions and practical Examples

GMP NEWS 2009

Personal Liability of the Qualified Person and Possibilities for Insurance

FDA limits Timeframe for Responding to a 483

EMEA Publishes Guideline on Replacement of Rabbit Pyrogen Testing

Recommended Event

GMP-Auditor Practice An advanced Auditor Course with many interactive Sessions and practical Examples

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