Olaf Kasemann

Validation & GXP & Project - Consulting

Project Management Services

    • Project Management

    • Project Execution Planning

    • Schedule Development

    • Fast Track Validation/Qualification Scheduling



Interim Manager Services

Interim Department / Team Management:

    • Manufactruing Department/Teams (Sterile Filling,

      Compounding, Solida, etc.)

    • Process and Plan Engineering

      Department/Teams

    • Validiation and Qualification Department/Teams

    • Quality Unit Department/Teams



GXP-Compliance

    • Business/GMP Process Analysis

    • Process Developmentand Improvement

    • Standard Operatrion Procedures,

      Generation and Update Services

    • Quality Manuals,

      Generation and Update Services

    • GAP Analysis in regard to EU/FDA Requirements

      and Expectations

    • GXP Traingns and Workshops

Validation Services

    • Process Validation

    • Cleaning Validation

    • Analytical and Sampling Method Validation

    • Qualification of Equipment & Utilities

    • Verification and Validation

    • Re-validation and Re-qualification

    • Tracebility Matrices and Risk Analysis

    • Validation Documantation,

      Reviews, Reports and Summaries

    • GAP I and GAP II Assessments



Quality Assurance

    • Q-Systems Reviews

      Development & Optimization

    • Validation Master Plans Generation and Update

      Service

    • Risk Assessments (GXP, Raw Material, Process,

      Cleaning, Utilities, Equipment, etc.)

    • Procedures and Documentation Review and

      Upgrade Services

    • Audit Preparation & Support

    • Auditing Services