Marta B. Email and Phone Number

Over 20 years industry experience.Experienced and recognized Quality Manager, auditor and PMManaged Global projects for sponsors and CROsPerformed multiple types of audits and/or assessments of documents, vendors, Phase I units, sites, systems/process across Europe, and Middle East.Currently providing following services:- Project Management, CRO and Vendor Oversight- GCP Compliance Services including audits, training, mock inspection, QMS, QA Consultancy and QA Continuous Improvement- Fraud and misconduct investigations- Deviation management- Auditing services:Investigational sitesVendors TMFCRO and Archive facilitiesSystem audits including for causeRegulatory Authorities Inspections Pre-Audits and Inspections HostingPreparing, hosting and responding to the Sponsors and RA Inspections (FDA, EMA, PMDA) - SOPs and Documentation Management / Change Control- Building-up System including SOPs, Templates, Forms - QMS Management: generating, proof-reading, review, release, withdrawal and tracking of SOPs, job aids forms, templates and work instructions