Olaf Kasemann

Validation & GXP & Project - Consulting

Quality Supoort Project, Compounding & Sterile Filling

  -  Leverkusen, Germany, Quality Unit, EU & US requirements

     •  QA Support Qualification/Validation Compliance

     •  Project Support Process & Documentation


Quality and Manufacturing Support Project, Compounding & Sterile Filling

  - Wasserburg, Germany, Quality Unit Department, Manufacturing Department, EU & US requirements

     •  QA Operations Support, Batch Record Reviews & GMP-Assessments & Closure of Deviations

     •  QA Systems Support, Assessment Qualification (Fill & Finishing, Packaging) & Deviation

        Management

     •  Manufacturing Support, Update of Master Batch Records, Closure of Deviations & CAPAs


Capacity Expansion Project, Compounding & Sterile Filling

  -  Leverkusen, Germany, Quality Assurance Biotech Department, EU & US requirements

     •  QA Project Support, Commissioning & Qualification (Compounding plant, Auxiliary Equipment, Small

        Equipment)

     •  Validation-, Qualification- & GMP-Compliance

     •  Cleaning Validation Support


Manufacturing Project

  - Linz, Austria, Documentation, EU & US requirements

     •  Generation of Transport Validation Protocol and Report


Manufacturing Department Interim Managament Project

  -  Singen, Germany, Compounding and Sterile Filling, EU & US requirements

     •  Interim Head Sterile Production (Compounding & Filling)

     •  Full Budget & Personnel Responsibility


Virus Safety Project

  -  Basel, Switzerland, Cell Culture Manufacturing, EU & US requirements

     •  Evaluation and Assessment of Virus Safety Concept of the Cell Culture Plant

     •  Audit Support


Manufacturing Support Project

  -  Singen, Germany, Compounding and Sterile Filling, EU & US requirements

     •  GXP Support, SOP Review & Updates, FDA Prep. Training

     •  Summaries and Presentations for Audit

     •  FDA Preparation Team Lead


Clean Area Concept in API Production, Support Project

  -  Ingelheim, Germany, API Manufacturing, EU & US requirements

     •  Generation of Interim Transition Report


Process Validation Support Project

  -  Marburg, Germany, Fractionation & Downstream Processing, EU & US requirements

     •  Generation of Process Validation, Stability and Impurity Profiling Reports


Laboratory Relocation Project

  -  Munich, Germany, Clinical & Development Laboratory, EU & US requirements

     •  Generation of Project Validation Master Plan

     •  Relocation Impact Risk Assessment


Virus Safety Project

  -  Schaftenau, Austria, Cell Culture Manufacturing, EU & US requirements

     •  Document and Summarize the Virus Safety Concept of the Cell Culture Plant for

        Authority Presentation & Submission


Engineering Department Interim Management Project

  -  Düsseldorf, Germany, Biotech Manufacturing, EU & US requirements

     •  Management of the PM, CM and CAL team (Clean Utilities, MFG and QC Assets)

     •  Support of Cross-functional Project Teams

     •  Implementation of a computerized Maintenance Management System  


Process Validation Support Project

  -  Marburg, Germany, Fractionation & Downstream Processing, EU & US requirements

     •  Generation of Process Validation and Impurity Profiling Reports


Conditioning Concept for Closed Equipment in API Production, Support Project

  -  Ingelheim, Germany, API Manufacturing, EU & US requirements

     •  ReportSummary of a Concept for Conditioning of Closed Equipment in API Production


Clean Area Concept in API Production, Support Project

  -  Ingelheim, Germany, API Manufacturing, EU & US requirements

     •  Generation of an Evaluation and Change Over Master Plan


Particulate Contamination in APIs, Support Project

  -  Ingelheim, Germany, API Manufacturing, EU & US requirements

     •  Documentation of Concept in regard to Particulate Contamination in APIs

     •  Generation of Final Report for FMEA Risk Assessment for Particulate Contamination in APIs


Process & Cleaning Validation Support Project

  -  Linz, Austria, Technical Service Department, EU & US requirements

     •  Generation of Submission Summaries for Process Validation & Cleaning Validation Projects  


Risk Assessment Project

  -  Schaftenau, Austria, Cell Culture Clinical Manufacturing, EU & US requirements

     •  Generation of Risk Assessment in regard to Raw Material

        (specification, regulatory requirements, testing, utilization & supply chain)


Process & Cleaning Validation Support Project

  -  Marburg, Germany, Fractionation & Downstream Processing, EU & US requirements

     •  Generation of Final Reports for Process Validation Projects & Cleaning Validation Projects

     •  Generation of Life Cycle Assessment Reports & Impurity Profile Investigation Reports


Production Support Project

  -  Düsseldorf, Germany, Biotech Manufacturing, EU & US requirements

     •  CCA Performance Qualification (Documentation, Management & Report)


QC & QA Support Project

  -  Schaftenau, Austria, Cell Culture Clinical Manufacturing, EU & US requirements

     •  Generation of Stabilty Report


Process Validation Project

  -  Schaftenau, Austria, Cell Culture Clinical Manufacturing, EU & US requirements

     •  Generation of Process Virus Validation & Scale Down Validation Report


Production Department Interim Management Project

  -  Düsseldorf, Germany, Biotech Manufacturing, EU & US requirements

     •  Interim Management of the manufacturing operations team (Upstream & Downstream)

     •  Support of Cross-functional Project Teams (QC, QA, PLE, SCM)

     •  Enforce measures to gain full GMP-Compliance within the manufacturing operation teams  


Risk Assessment Project

  -  Schaftenau, Austria, Cell Culture Clinical Manufacturing, EU & US requirements

     •  Generation of Risk Assessment in regard to Cross Contamination


Process Validation Project

  -  Unterach am Attersee, Austria, Technical Operations Department, EU & US requirements

     •  Process Validation, Concepts & Requirements, Support

     •  Sterile Filter Validation, Concept & Documentation Support

     •  Generation & Reviews of Process Validation Protocols & Reports

     •  Execution & Coordination of Process Validation Projects


Quality Assurance Support Project

  -  Vienna, Austria, Quality Assurance Department, EU & US requirements

     •  Quality Assurance Support, Extension of Manufacturing Site:

         Assessment of Change Controls and Deviations

     •  Validation Compliance Support, Quality Systems Support

     •  Validation Master Plan & Validation Project Plan

     •  Validation & Qualification Reviews


Business Process Optimization Project

  -  Frankfurt, Germany, Quality Control Department

     •  Business Process Optimization, Quality Control Labs, Evaluation, Analysis, Action Plan, Follow up

     •  Management Process Optimization, Quality Control Department; Management, Evaluation, Analysis

     •  Project Management, Process Optimization Quality Control Laboratories


cGMP - FDA, EU Compliance Project

  -  Frankfurt, Germany, QC, Downstream & Filling Processes, EU & US requirements

     •  FDA-Compliance Upgrade in Quality Control Unit

     •  Project Management Support, Sub-Project Manager QC

     •  Review and Assessment of Quality Systems(Change Control & Deviation Management & OOS),

         Documentation, Processes and Procedures

     •  Validation / Verification Quality System Definition, Implementation, Documentation and

         Performance Support

     •  Qualification Analytical Equipment, Documentation, Performance and Performance Support

     •  Raw Material Testing, Specification and Testing Documentation

     •  Review and Update of Testing Procedures for Final Products

     •  Method Validation for Row Material and Final Product Testing

     •  Bioburden Control Strategy, Concept and Requirements Support

     •  Cleaning Validation, Concept and Requirements Support

     •  Internal Audits (QC Laboratories, LSO Recall-Process)


IMPD Submission Project Support

  -  Biedenkopf, Germany, Biotech Product, US requirements

     •  Review & Summary Method Validation, IMPD-Submission


Process Validation Project Support

  -  Boca Raton, USA, Product Downstream, US requirements

     •  Review and Assessment of Process Validation Documentation

     •  Process Validation Concept and Requirements Support


Regulatory Project Support

  -  Frankfurt, Germany, Downstream & Filling Processes, EU & US requirements

     •  Review & Assessment of Final Reports for Submission, Qualification & Validation Documentation


Cleaning Validation Project

  -  Vienna, Austria, Solida Production, EU & US requirements

     •  Cleaning Validation Concept and Documentation

     •  Analytical and Swab Sampling Method Validation

     •  Project Management Support, Sub-Project Manager CV


GMP Support Project: Production Plant and Utilities

  -  Vienna, Austria, Downstream Processing, Utilities, EU & US requirements

     •  Project Management of Commissioning and Qualification Tasks

     •  Risk Assessment GMP, Product, Environment, Health and Safety

     •  FAT, SAT, Qualification Documentation

     •  Change Control & Deviations: System Definition and Management


Process Validation Project, Lyophilization

  -  Marburg, Germany, Lyophilization, EU & US requirements

     •  Process Validation Concept and Requirements Support

     •  Generation of Process Validation Documentation

     •  Generation of Reports for Authority Submission


Qualification Project: Packaging Machine

  -  Vienna, Austria, Solida Production, EU & US requirements

     •  Qualification Concept and Documentation

     •  Review and Assessment of Vendor Documentation

     •  Qualification Performance and Final Report

     •  Project and Change Management


De-Bottlenecking Project

  -  Basel, Switzerland

     •  Assessment of potential Yield Improvement Capabilities in regard to

     •  Regulatory and Inventory Impact, Business Risk and Phasing

     •  Estimation of Costs and Benefits


Contract Filler Technology Transfer Project

  -  Manchester, GB, Aseptic Contract Filling, EU & US requirements

     •  Technology Transfer of Aseptic Filling Process

     •  On Site - Project Management Support

     •  Establishment of Compliant Process Documentation

     •  Review and Assessment of Qualification and Validation Documentation

     •  Review of Quality Systems (Change Control & Deviation Management, Qualification & Validation),

         Evaluation of general GXP-Compliance Status


Documentation Review Project: Granulation Equipment

  -  Vienna, Austria, Solida Production, EU & US requirements

     •  Review and Assessment of Vendor Documentation

     •  GAP Analysis


Cleaning Validation Project

  -  Vienna, Austria, Solida Production, EU & US requirements

     •  Project Management, Project Manager

     •  Cleaning Validation Concept and Documentation

     •  Analytical and Swab Sampling Method Validation

     •  Revalidation and Change Management Concept

     •  Validation Performance and Final Reports


FDA Pre Approval Inspection Support Project

  -  Nottingham, GB, API-Manufacturing and Filling, EU & US requirements

     •  Audit Preparation & Support (FDA PAI)

     •  General GXP-Compliance Status

     •  Review of Quality Systems