Transcription of EU GMP Requirements
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EU GMP Requirements
Trade & Industry Inspection Agency ofLower Saxony / Germany, Hannover officeBernd BoedeckerGMP Inspectorate of Hannover / GermanyEU GMP Requirements - Quality Systems -at Turkish Ministry of HealthAnkara, 20-21 Oct 2009 Trade & Industry Inspection Agency ofLower Saxony / Germany, Hannover officeTMH, Ankara, 20-21 Oct 2009 Bernd Boedecker2contact dataBernd BoedeckerStaatliches Gewerbeaufsichtsamt HannoverDezernat 74 (GMP Inspectorate)Am Listholze 74D-30177 Hannoverphone: +49 (0)511 / 9096-464fax : +49 (0)511 / & Industry Inspection Agency ofLower Saxony / Germany, Hannover officeTMH, Ankara, 20-21 Oct 2009 Bernd Boedecker3 Biodata of the speaker Name:Bernd Boedecker Nationality:German Education:Qualified pharmacistCertified expert for Pharmaceutical Technology Current position:GMP Inspector (since 2006) Further professionalbackground:Pharma industry (1984 - 2005) various R&D-based companiesmostly at interface Development vs.
Risk analysis – the estimation of the risk associated with the identified hazards [dtto.] Risk reduction – action taken to lessen the probability of occurrence and the severity of that harm [dtto.] Risk acceptance – the decision to accept risk [dtto.] Stakeholder – any individual, group or organisation that can affect, be
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