Dennis Berger
Computer System Validation (Csv) Consultant @Pinnaql
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WORK HISTORY
Computer System Validation (Csv) Consultant @Pinnaql
King of Prussia, PA, US
Engage with clients to evaluate instrument and system use software capabilities to develop user requirement specifications.• Author and update laboratory instrument, process, and safety standard operating procedures.• Develop computer system validation documents such as consolidated validation plans/reports and user acceptance testing scripts to facilitate process improvements for laboratory instruments to be FDA 21 CFR Part 11 and GxP compliant.• Perform risk and data integrity assessments.• Identify gap and root cause analysis, corrective and preventive action reporting, handling, and closing of identified defects and findings• Support change management activities for cGMP computer systems and other related activities.
EDUCATION
Wilmington University
Master of Business Administration, Business Administration, Management and Operations
University of Delaware
Bachelor of Science, Biomedical Sciences
ABOUT DENNIS BERGER
I specialize in navigating complex IT landscapes within the Life Sciences industry to ensure strict GxP compliance and data integrity. I bridge the gap between technical teams and Quality Assurance by managing the full validation lifecycle, from URS development to validation summary reports. My focus is on computer system validation that meets regulatory requirements (21 CFR Part 11) while accelerating project timelines. Expert in supporting audits, SOP development, and leading high-stakes validation projects.
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