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