Computer System Validation & Compliance Specialist
Deena VeneziaMBA
Computer system and LIMS validation, gap assessments, and running the back room during FDA audits.
- CSV
- LIMS
- Change Control
- Gap Assessment
- Project Management
25+ years in pharmaceutical and device industry
Background
Deena Venezia has more than 25 years of experience in the pharmaceutical and medical device regulated industries. Her expertise covers project management, computer system validation, LIMS validation, operations management, GMPs, compliance and laboratory auditing (gap assessments), investigational skills, and change control management systems.
She is highly experienced working the back room during FDA audits and mentoring the individuals involved. She directs and designs compliance initiatives — corrective action plans to remediate quality systems — for executive management and provides oversight during implementation.
Deena speaks fluent German.
What Deena does on an engagement
- Computer system validation and CSA
- LIMS and laboratory system validation
- Change control system design
- GMP gap assessments and corrective action plans
- Audit back-room management and staff mentoring
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Describe the product, the process or the problem. We will tell you honestly whether we are the right people to help, and who should be on the team if we are.