Over 15 years experience in the life sciences industry including: Computerized System Validation (CSV) and Computer Software Assurance (CSA), Project Quality Management (PQM), IT Quality management, digital transformation, business and technology consulting
Expertise in computerized system validation, risk management & remediation assessments, global quality, operations, manufacturing and IT development processes
Proven track record in leading cross-functional teams to complete projects on time and within budget, using Lean Six Sigma, Agile/Scrum and Waterfall methodologies. Ability to facilitate, coach and deliver results.
Certified Quality Auditor (CQA) by the American Society for Quality (ASQ), Certificate number: 75336, for ISO and GxP audits of Suppliers to life sciences companies.
Expert knowledge of industry regulations and guidelines: GAMP5, FDA 21 CFR Parts 11, 211, EU Annex 11, ISO9001, ISO13485, ISO14644, ISO15378, ISO17025, ICH Quality Standards
Faculty member at ECPM – University of Basel, Switzerland
- Speaker: ‘Digital Data Collection and Protection’ – Part of teaching module on Ethical and Legal Aspects of Clinical Trials. University of Basel, Switzerland. November 2018, Basel
- Speaker: ‘Data Integrity Assessment and Risk Management Approach for the Life Sciences Industry’ – Annual Swiss Symposium in Pharmaceutical Medicine. SwAPP, sgpm/aspm. November 2018, Zurich
Ilias Christodoulopoulos, Ph.D.
CSV & CSA expert and founder of CCG Solutions GmbH
phone: +41 (0) 79 650 5553, email: contact@ccg-solutions.net