Dr. Andreas Ockenfels

GMP and GLP consultancy and support

I offer consultancy and support in the following areas:

  • Quality assurance
    Maintenance, implementation or optimisation of quality systems, particularly under GLP and GMP
  • Quality control
    Qualification of raw materials, performance of analytical method validations and transfers, preparation of test documentation
  • Manufacturing
    Document preparation and review, support for process optimisation, validation or transfer
  • Interim management
    Quality management and quality control
  • Training
  • Processing of changes, deviations and CAPA, complaints and OOS
  • Audits to GLP, GMP, ISO 9001, 13485, 17025 etc.
  • Qualification, validation
    Equipment, computerised systems and Excel spreadsheets
  • Risk analysis
    Quality processes, changes and deviations, analytical test methods, manufacturing processes
  • Supplier qualification
    Selection and audits
  • Quality agreements
    For contract services or subcontracting
  • Project Management
    Planning, monitoring, reporting

Profile:

  • Doctorate in Chemistry
  • Over 20 years of international experience in the pharmaceutical industry
  • Several years in quality assurance management positions in service organisations for quality control and manufacturing, especially for biopharmaceutical products
  • Various projects in quality assurance, quality control and manufacturing in the pharmaceutical, biopharmaceutical and medical device industries, including interim management
  • In depth expertise in GLP and GMP quality assurance including implementation or optimisation of quality systems
  • Extensive expertise in quality control including analytical method validation and transfer
  • Experience in manufacturing process optimisation, process validation and continuous process verification
  • In-depth knowledge of conducting audits and supporting inspections by European authorities or US FDA