E-Records Quality SME, Lowell, MA, USA.

Orlando López is recognized as a global technical expert in e-compliance and e-records integrity regulations/guidelines (Part 11, EU Annex 11, MHRA, WHO, PIC/S, CFDA, USFDA, CEFIC, TGA, JPMH). Knowledge of the SLC, e-records QA, CSV, and infrastructure qualification.

Experience:

• Pharma, biotech, and medical devices sectors e-compliance for companies such as Allergan, Catalent, J&J, Lilly, Novartis, Pfizer, Sanofi, and Thermo Fisher in the country, regional and global roles.
• Subject matter expert (SME) in the interpretation and application of e-compliance regulations and standards
• Practical experience with e-records integrity assessment and e-records integrity remediation plans.
• Direct participation in regulatory inspections, response activities, remedial action plans, and consent decree remediation as a Verifier.