Frank Wallrafen
Dipl.-Ing.
Inhaber - Wallrafen Consulting(The company name is only visible to registered members)
- 52089 Aachen
- Germany
Personal information
- Haves
- Know How zu Life & Science, Health Care / Pharma: Computer System Validation (CSV), Validierung, GXP Compliance (EU-GMP, GCP, GLP, GDP), FDA - Compliance, FDA Inspektionsvorbereitung, CAPA, Audits, Compliance Management, Qualitätsmanagement, Qualitätssicherung, Quaility Assurance, 21 CFR 820, 21CFR Part 210, 21 CFR Part 211, 21 CFR Part 11, ICH Q8, ICH Q9, ICH Q10, ISO 14791, Risk Management, Risikoanalyse, ISO 13485, Medical Devices, Medizintechnik, PAT-Consulting, Prozessberatung, Prozess und Organisationsentwicklung, Projektmanagement, Training, Coaching IT-Qualitätsmanagement, IT-Infrastruktur
- Groups
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Professional experience
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Apr 2010
- present
(2 years, 2 months)
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Inhaber - Wallrafen Consulting
(The company name is only visible to registered members)
Industry: Consulting, im Bereich IT-, Medizin-, Pharma- und Life-Science-Industrie Schwerpunkt: - Compliance & Quality Management (GRC, PAT, QMS, Risikomanement, Audits) // Valdierung von System, Anlagen und Prozessen // IT Management // - Labor Managment (KPIs, Prozesse und Systeme)
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Apr 2010
- present
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Jan 2006
- Mar 2010
(4 years, 3 months)
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Manager Core Service Compliance / Key Account Manager
DHC Dr. Herterich & Consultants GmbH, http://www.dhc-gmbh.com
Industry: Consumer Services, Consulting im Bereich Life Science - Schwerpunkt Quality Management, Phama, Prozessindustrie, Qualitätsmanagement, Logistik, IT, Validierung, LIMS, CDS ...
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Jan 2006
- Mar 2010
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Jan 2001
- Dec 2005
(5 years)
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IT-Manager / LIMS and Validation Expert
Industry: Pharmaceuticals
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Jan 2001
- Dec 2005
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Industry:
- Employment status
- Executive
Educational background
- Languages
- German (First language), English (Fluent), Dutch (Basic knowledge)
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