Luis Maldonado's Linkedin Analytics

Providing Boutique Fractional Subject Matter Expertise to the Pharmaceutical, Biotech, and Medical Device Organizations with training, Information Security and #Risk Management #IT Project Management, Data Classification, #ISO 27001, #IT Compliance, #ITIL processes, #Computer Software Assurance, Computer Systems #Validation, Quality Management Systems, #Data Integrity, IT & QA #Compliance, Clinical Data Management, #Infrastructure Qualification, #Remediation Activities, #SOP Development, and #GxP #Audits readiness. Specialties: IT Standards, Risk Management, #Cybersecurity, Process Improvements, GAMP, IT Quality, #Quality Management System, Computerized Systems Validation, Infrastructure #Qualification, IT Governance, Talent Development and #Coaching, #GDPR, #NIST, Policy and Procedures, COBIT, #COSO, Internal and External Audits, 21 CFR 820 - Quality System Regulations, 21 CFR Part 11 - Electronic Records; #Electronic Signatures, 21 CFR 50, 210, 211, Software Quality Assurance, #GAMP, #ITIL, #SDLC, Annex 11, GEP, SOX, gap remediation. Speaking Engagements • Guest Speaker for International Pharmaceutical Academy on Internal and External Audits 2009 • Guest Speaker for International Pharmaceutical Academy on Computerized Systems Validation 2010 • Invited Guest Speaker for Guest Speaker for International Pharmaceutical Academy 2011 Industry • Good Manufacturing Practices/Quality System Requirements and Industry Practice Association for the Advancement of Medical Instrumentation (AAMI) • Process Validation Requirements & Industry Practice (AAMI) • Design Control Requirements & Industry Practice (AAMI) • Validation Process/ Quality System Requirements and Industry Practice (AAMI) • Computerized and Process Validation (Eduquest) • Information Security Officer Course (SANSFIRE) Auditing • ISO Lead Auditor 9001 (RABQSA) • Computer Information Systems Auditor (CISA) • ASQ Quality Auditor • Novartis Auditor courses include Auditor, Analytical Laboratory, and Computer System Validation • 21 CFR Part 11 Electronic Records and Signatures Auditor (Eduquest) • SOX Auditor (RSWG) #ITCompliance #Coaching #Mentoring #Training #ITProjectManagement #SOP #GapAnalysis #Remediation #DataIntegrity #Biotech #Pharma #MedicalDevice #Clinical #QMS #SOX #ITIL #Remote #Startups #Validation #Methodology #Standards #SOX #IRM #GRC #Audit #Readiness #COBIT #NIST #ITRiskManagement