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).
Areas of Expertise
Biochemistry, Computer science and engineering, Clinical Drug Development, History, Political Science (National and International), Philosophy, Medical Device Design, Firearms, nuclear strategy, England
An idea worth spreading
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...
I'm passionate about
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!
People don't know I'm good at
Close Quarter Combat!