Senior CSV Expert | 10+ years experience | FDA/EMA Audits
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About me
I've spent 10 years validating computerized systems for pharmaceutical, biotech, and medical device companies. With over 40 successful FDA and EMA inspections under my belt, I've achieved zero 483 observations related to cloud system validation.
My expertise spans Salesforce, Veeva Vault, AWS, Azure, and numerous other cloud platforms. I've validated everything from Quality Management Systems to complex data lakes for clinical trials.
In this course, I'm sharing the exact framework I use to pass audits - the same strategies that have saved my clients millions in compliance costs and validation time.