PharmOut

Entries by PharmOut
application PIC/S membership

PIC/S launch new website

PIC/S have just released a new, responsive website that allows for easy viewing on both desktop and mobile devices. The website reflects the change from the black and white PIC/S logo to the red, …

Surprised man

US FDA continue to find Data Integrity violations

Within the last 30 days, the US FDA released two new Warning Letters and yes-you guessed it, all contain data integrity violations. Lets look them below:
Falsifying test data from a stability batch
The latest Warning Letter is …

ISO 13485 2016 is here… what now?

This very practical question seems to be on everyone’s lips, ‘ISO 13485 2016 is here, what do we do now?’
With a three year transition period proposed (N233 Draft White Paper – ISO Transition Planning …

Congratulations to Alan Loughlin – Senior Consultant

PharmOut is delighted to welcome Alan Loughlin, to the role of Senior Consultant.
Alan is one of our validation professional specialising in computer systems validation.

Alan has successfully led CSV projects across the Asia Pacific region …

Interim staff

Congratulations to Debbie Parker – Lead Consultant

PharmOut is delighted to announce Debbie Parker, to the role of Lead Consultant.
Debbie Parker has over 25 years industry experience covering GMP, GLP, QA, QC, quality management systems, investigations, auditing, audit remediation, training, technical …