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DATA ANALYTICS & REGULTORY INSIGHTS are passions - I share EXAMPLES and TRENDS ๐ Presenter, author, collaborator & problem solver. โ WHY I CAN HELP YOU ? I am a critical thinker & visual learner & problem solver. I create content that shares key insights through: articles, brochures, flyers, presentations, publications, reports, training workshops, videos and webinars. My skill endorsements and profile recommendations are from my +37 yearsโ experience of collaborating, facilitation, focus, sharing knowledge, creative thinking and delivering results. From a specialist interpreting and modelling polymer properties against FT-IR & FT-Raman spectra, I evolved through Analytical, Management, Project, Scientific and Leadership roles. My Agilent role enables me to apply and share my knowledge in my global marketing work and thought leadership compliance focus. Expertise includes transforming data into visual information for insight. A contributor, presenter and steering committee member, I actively support GAMP. I am a Chemistry graduate (BSc) with an MSc in Analytical Chemistry and NLP Master Practitioner. I achieved professional chartered status as a Chemist (CChem), Scientist (CSci) and Member of the Chartered Management Institute (MCMI). ๐๐๐๐๐๐ ๐ ๐๐๐ ๐ ๐๐๐๐๐๐ ๐๐๐๐๐๐๐ - it motivates me to grow and help others. I support people, teams and share my technical input to ensure projects balance commercial, strategic & regulatory needs. I apply critical thinking through Kepner Tregoe and NLP facilitation to investigate problems. Recent areas of insight focus are DATA INTEGRITY, REGULATORY TRENDS and USP <1058>. WHAT IS DATA INTEGRITY? I am trained by Monica Cahilly and Peter Baker. Fundamentally it is applying meaningful interpretations of core ALCOA+ principles - through workflow mapping. WHY EXAMINE FDA DATA? To learn from others' mistakes and FDA findings (FDA share more data than other regulators). Trending FDA findings creates insight. USP<1058> - SO IMPORTANT? Instrument Qualification is the Analytical Foundation of Quality lab data. USP <1058> is the only "MAJOR" pharmacopeia chapter on Analytical Instrument Qualification, giving it global significance. Satisfying the data quality triangle and life-cycle framework of<1058> simplifies lab audits. PHARMACOPEIA FOCUS โบ USP<1058> โบ USP<621> โบ USP<854> โบ USP<1220> AUTHOR &, SPEAKER โพโพโพโพโพโพโพโพโพโพโพโพโพโพโพโพโพโพโพโพโพโพโพ โบ ๐๐๐๐: - Compliance articles in my profile โบ ๐๐๐๐๐ ๐๐๐: - To explore writing collaboration โบ ๐๐๐๐๐๐: - Me to present & share my insights
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