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Jessica Siefert

About Jessica Siefert

Senior Consultant, (GMP-) Auditor und Trainerin

 

  • Expertise in Projekt- und Programmmanagement
  • Qualitätssicherung und Datenintegrität
  • Vorbereitung auf Zertifizierungen und Akkreditierungen
  • Prozessoptimierung nach globalen/regulatorischen Standards
  • Vertraut mit European Directive/Regulation EU, FDA 21 CFR part 11, ISO 13485, HACCP, IFS, ISO 9001, ISO 19011, ISO 27001, ISO 17067, ISO 17029

 

Branchenschwerpunkte: Pharma, Food & Beverage

Entries by Jessica Siefert

GMP

Mastering GMP audits successfully: What really matters

GMP audits are one of the key quality assurance tools in the pharmaceutical and life science industry. They check whether manufacturing processes, documentation, systems and working methods comply with regulatory requirements at all times. This is not just about compliance with formal requirements, but also about ensuring product safety, process stability and quality in practice. […]

3 weeks /by Jessica Siefert
Recent
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    Mastering GMP audits successfully: What really matters3 weeks 
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    Business continuity management: How companies strategically...2 months 
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    Continuous manufacturing: future trend in the pharmaceutical...24. September 2025 - 18:35
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    GxP audits: How important are they and how are they con...28. October 2024 - 12:20
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AI AI Annex Annex 11 Artificial Intelligence Audit audits Business Continuity Management Cannabis Certification Clean room Computerized systems Continuous Manufacturing CRA Cultures Cytostatics Data Integrity DORA Draft Germ count Germ count monitoring GMP GXP Health insurance Information security inspections ISMS ISO/IEC 42001 ISO 9001 ISO 27001 ISO standard Laboratory Machine Learning NIS-2 NIS2 Pharmacy QMS Quality management system Reagents Regulations Retaxation Sustainability Transformation

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