Gordon Pendleton

Background

About Gordon Pendleton

A dynamic and highly skilled Quality Consultant with over 30 years’ experience with various high/low volume technologies, Pharma/Bio-Sciences, Medical Devices, Dental, Cosmetics (disposable/consumable, reusable/active devices, implants), Drug FDA CR 210/211 and IVDs (reactive and active) gained whilst working for many global healthcare companies. Health Canada MDSAP, FDA/USA, Australia and Latin America’s Brazil, Mexico etc.) Design Dossier/Technical Documents creation, gapping, remediation, review & approvals and local submissions lead with NB, CA and local importer/Distributor support, including Economic Operator SME. Clinical Trials/Investigating Global Auditor and HIC reviewer to FDA and EU Regulations, including multi-centre randomized trials/Studies for Global selected study sites, supporting the Lead Investigator in studies protocols, selection of subjects, site selection and Report Documentation. 6 Sigma trained and experienced. EDUMED listing, maintenance and reporting SME, interactions with Notified Bodies (EU-CE & UK-CA), Global Regulatory Agencies (MHRA, FDA Health Canada ANVISA, EU, NMPA-CFDA, MFDA, TGA, ANMAT etc, full submissions pack (Clinical, Technical, QMS, Risk etc.)creation and maintenance/Changes, Vigilance reporting and agent/distributer, import local support. SE in Global complexity NPI on IVDR/IVD clinical studies, Usability, full QA, QC and RA activities working with design and clinical stakeholders and internal and external team. FDA CFR 820 and all impacting CFRs, including Guidance. 510k, PMA and De nova FDA including Pre-Subs and FDA Submissions and application, SME on NDI PRE-Clinical, Performance trails, Usability, QRM/DFMES- acts as the independent person on projects. Clinical Study, Clinical Investigations/Trials CER. Clinical planning to IVDR/MDCG and GSPR and all FDA and other Global Market submissions and maintenance of such, including OTC Pharma products. Design, Clinical SME and Change control Lead and creates, plans and executes with the various teams and stakeholders. Experience as a “Section Lead Auditor” in FDA (USA, CFDA, TFDA etc.) and Remediation and Improvement Programs, for Notified Body formal review and acceptance. Including: Technical File/Design Dossier/Technical Documentation (2017), CAPA, Validation, Process Controls, Risk Management and Verification activities. Worked as an independent reviewer on all FDA remediation-related revisions to policies/procedures/WIs. CSV FDA Guidance & CFR820 (process, SAP/SOP etc.) and FDA Part11 creator, reviewer and auditor.