I’m a Quality Management Systems leader who has a holistic and comprehensive understanding of the entire lifecycle of electronic Pharmaceutical Systems including Document, Learning, Quality and Information Security Management Systems.

Through years of hands on experience, I am able to “speak” all Pharma languages including GLP, GCP, GMP, GDP, and GPvP which in turn allows management systems to be correctly configured and “right-sized” based on a common understanding of regulatory expectations.

My goals include leading companies through both Quality and Digital transformations utilizing “keep it simple” methodology. I believe Management Systems and associated processes should be commensurate with the company size, resources, capabilities and, of course, direct impact to patient safety, product quality and data integrity.

Management System processes and configurations do not need to be difficult nor complex to be highly effective.

Areas of Expertise

 

Quality / Electronic Systems

  • Veeva Quality Suite

  • Master Control

  • Compliance Wire

  • TrackWise

  • Documentum

  • Dialog and Drug Safety Triager (PV)

  • JIRA

  • IRMS

Quality Management Activities

  • Document Management

  • Exception Management (QE/CAPA) & RCA

  • Change Controls

  • GxP Training

  • GxP Vendor Management

  • GxP Auditing (Internal/External)

  • Product Complaints

  • Risk Assessments / Management

  • Batch Record Review

  • Literature Review Processes

Systems Implementation, Validation and Security

  • System implementation (e.g. Veeva, MasterControl), testing and Go Live activities of Quality Systems including project management, “right-sizing” configuration, migration, roll out, administration and training activities.

  • Software Development Life Cycles including development and documentation of:

    • Agile / Waterfall Development

    • URS/FRS

    • Configuration Specifications

    • Traceability Matrices

    • Validation Protocols, IQ/OQ/PQ, and Summary Reports

  • Amazon Web Services

  • Security Controls (ISO 27001, GDPR, Penetration/Vulnerability Testing)

Modalities

  • GLP

  • GCP

  • GMP

  • GPvP

Regulations/Standards

  • 21 CFR parts 11, 210, 211, 314, 803 and 820

  • FDA CSA

  • EMA Annex 11

  • ERES (JP)

  • ICH Q7, Q9 and Q10

  • GAMP 5 (Compliance and Testing)

  • ISO 9001:2015, 13485:2016, 19011:2018, and 27001:2013

Awards

 

Panels and Publications

Panelist: Veeva Quality Summit 2018:

  • 5 June 2018 (note - original website has since been removed, link is to historical web page via Internet Archive)

  • Topic: “Technology Considerations and Recommendations Before Embarking on a Quality Transformation Project”

Whitepaper: “Quality Management and Validation in Pharmacovigilance Software”:

  • March 2018

Publication: Pharmaceutical Information and Pharmacovigilance Association- Co-Author – Issue 55: “Quality Management and Validation in Pharmacovigilance Software”:

  • April 2018

  • Note - Original Whitepaper drafted was adapted by Tessa Heffernan and submitted for publication.

Resources