Looking forward to the next inspection?
I can help increase your process Audit readiness with my 20 years' experience (GMP, GLP, GDP, GDocP, SOX, EHS, IT & Data integrity) to strengthen your compliance and set up a mitigation and action plan.
From 2004 onward I have participated in, presented at, as well as led, several Audits and Audit preparation activities for Internal reviews & Corporate audits, as well as official FDA, AGES (Austrian Agency for Health), and several other countries inspections (such as China, Japan, Mexico, Turkey, Canada, etc). My experience across two industries (Pharma and IT) and expertise among several different organizations (IT & Data Integrity, Laboratory, Logistics and Warehousing, Manufacturing) puts me in a unique position to take a critical look at your processes and help you determine whether reality meets expectations.
I have spent many years performing weekly GEMBAs across various teams, sites and processes, looking not only after the health and safety of my employees (EHS) but also at the compliance status and potential gaps.
After all, you might be prepared on paper, but is the shop-floor really following those processes?
So let us have a free consultation regarding your auditing needs, so we can determine together what should, could and needs to be done to bring your organization to the next level of compliance.
As of October 2024 I have a certification as Internal Quality Auditor (TÜV®) Process-Oriented Auditing of Management Systems acc. to ISO 9001:2015
