1. Global expertise with Pharmaceutical/Biotechnology and Medical Device cGMPs and related FDA Quality Management Systems thinking. Key focus on the Aseptic Processing of Biologics - Fill-to-Finish. (Leveraging FDA Guidance 'Sterile Drug Products' - September 2004 and 'Process Validation' - January 2011). Strong Project Management skills, aligned with PMBOK thinking (ANSI/PMI 99-001-2008) and PRINCE 2 approaches.
2. Interested in the challenges linked to FDA 'Consent Decree' situations' - (FDA 'Conflicts of Interest', Regulatory, Technical, Cultural and Program Management) and the ultimate impact on national and international availability of key therapeutic agents/medical devices. Quality Systems SME on three 'major' FDA Consent Decree sites.
3. Background with: Automation (process and data) - RISK BASED - CSV - Computer System Validation - ISPE GAMP 4/5, FDA, EudraLex, Annex 11, Volume 4 - thinking on CSV, SDLC Approaches suitable for regulated industry. Certified Software/Hardware Systems Engineer - ITIL (ISO 20,000), CCNA, CCDA, MCSE, MCT - Cisco/Microsoft/IBM & The Gartner Group. (Original Contributor to this Knowledge Domain for the ISPE - CPIP Credential). GAMP 5 Alignment with ITIL and COBIT best practices. SharePoint CSV background - SharePoint as a GxP solution to data automation in regulated industry. Strong ISO background - 9000/9001, 13485, 14971, 19011. Certified by GEHC as Supplier Auditor - under ISO 9001/13485/21 CFR 820, and 19011 - mapping to ASQ CQA Certification.
Fellow of the Royal Society of Chemistry (FRSC), London England. RAC Credentialed - Regulatory Affairs Professionals Society. True CSV Expert - ITIL Certified, GAMP 4/5, Certified IT Systems Engineer (Microsoft, Cisco, IBM, and The Gartner Group).
You name it - and I am likely interested. I am totally serious - I may not be the smartest chap - but I am intrigued by almost everything - the kid who never grew up!
Always SEEK FIRST to understand a thing before trying to be influential and changing a thing - so it is not original, but - wow folks rarely practice this simple idea - now we can shoot ideas and opinions into the InterGoogle with such ease...
Close Quarter Combat!
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