Frank H.-Head of Quality

• Support for the IT department on various IT-related quality aspects
• Documentation of ongoing IT infrastructure requalifications, including the corresponding risk assessment
• Windows server upgrade: preparation of qualification documents (operation of SQL cluster, requirements specifications, technical design, risk analysis)
• Support for the upgrade of the serialization database / interface: documentation of user role migration
• Support for supplier qualification, including supplier audit (DMS and RA system implementation)
• Adaptation of the supplier qualification SOP
• Review and adaptation of the supplier risk control matrix
• Review of supplier qualification documents and comparison with the risk control matrix
• Preparation of supplier audit (remote)
• Conducting supplier audit (remote) as lead auditor
• Preparation of audit plan and audit report

• Concept for a quality system for a 4PL business
• Development and implementation of a GDP quality system for the business as a 4PL provider
• Preparation for an inspection by the competent authority, including registration and WDA application
• Support in establishing the business based on GDP requirements

• Active support of responsible person §52a AMG
• Re-structure quality-system (global with affiliate)
• Set-up and implement new quality agreements (global with affiliates)
• Updating of all necessary GDP SOPs and forms for operational GDP activities
• Preparation of GDP inspection through the authorities (GAP-analysis)
• Support understanding and set-up of quality-system as pharmaceutical company (local representative and co-distributer)
• Set-up supplier qualification system
• Restructure complaints handling and interaction with German graduated plan officer (Stufenplanbeauftragten §63a AMG)
• Backlog processed (changes, deviations, CAPA)

• Provision of the function as responsible person §52a AMG
• Provision of the function as responsible person for APIs
• Support of the quality system (analysis and updates)

• Generation of SOPs for aseptic manufacturing: feeding of primary packaging material, cleaning and sterilization of the manufacturing facility, material and personnel transfer, primary packaging assembly, cleaning and sterilization bottling plant, autoclave, room decontamination
• Coordination with the subject matter experts

• Implementation of an electronic document management system (SOP Edition, triboni AG)
• Software validation based on GAMP5 / 21 CFR Part 11
• Consideration and assurance of data integrity requirements
• Risk assessment for validation
• Software training (administration and users)
• Project management (coordination and organization of validation with customers, including qualification tests)

• Equipment qualification (liquid nitrogen container, ultra-low freezer, alarm system)
• Risk analysis of equipment and systems
• Preparation of qualification documents
• Project management and communication with suppliers
• Creation of periodic review documents (qualification status)
• Support for the quality assurance system (consultant)

• Methods and knowledge transfer (combinatorial medical devices) for incoming goods inspections from development to the quality control departments
• Implementation of GAP analyses (methods, GMP compliance, data integrity)
• Implementation of risk assessment (methods, GMP compliance, data integrity)
• Establishment of transfer documents (GMP)
• Implementation and documentation of the transfer
• Project management (coordination and organization of transfers, coordination with QA)
• Consulting and implementation of data integrity

• Qualification IT infrastructure, incl. documentation
• Creation of operating documents of the IT structure components and IT qualification documents
• Qualification / validation GxP relevant back-up system (CSV), incl. documentation
• Support of GAP and IT risk analysis
• Conceptual GxP consulting on IT processes taking into account the current data integrity requirements
• Creation of a holistic container closure integrity test (CCIT) concept for a new product to be introduced
• Dossier for the preparation of an FDI inspection with regard to CCIT presentation
• Gap analysis and actual state considering required conditions from USP 1207
• Consultation and integration of all CCIT stakeholders affected in the product cycle
• Project management
• Advice on the selection of new CCIT methods, including creation of CCIT requirements profile with data integrity requirements and supplier visits

• Support of the responsible person GDP
• Process and quality management
• Implementation and support of serialization project (CMO onboarding, validation support OQ/PQ, creation of relevant SOPs, data integrity)
• Support establishment of a quality assurance system according to GMP / GDP
• Consulting document and data management solution according to GMP
• Participation in ongoing deviation change and CAPA processes
• Training of employees: QM system and DMS

• Consulting and project work: process and quality management
• Support for establishing a quality assurance system according to GMP
• Consulting on document and data management solutions according to GMP
• Employee training: QM system and DMS

• Establishment of a virtual quality assurance system for pharmaceutical wholesalers
• Implementation of an electronic SOP management system and quality assurance system
• CSV, computer system validation
• Establishment of a quality assurance system for obtaining the wholesale operating license according to AM-HandelsV (GDP)
• Creation of all relevant SOPs and quality documents
• Preparation and CAP analysis for the implementation of the GDP guideline
• Member of the team implementing the GDP guideline at international level
• Project management
• Development, establishment, and implementation of extended quality management: change control, variances, CAPA processes, risk management

• Supervision / support of electronic SOP management as a service
• Change management and documentation of the software
• Risk management for IT processes
• Training on the application
• Validation of the software (CSV) and continuous maintenance of the validated state
• Data integrity responsibility and implementation

• Consulting and project work: process and quality management
• Establishment of quality assurance system according to GMP (incl. self-inspections)
• Construction of aseptic production unit
• Establishment of process chain for biological drugs according to GMP
• Implementation of document and data management solution according to GMP
• Validation (CSV) of the software
• Responsible for data backup and recovery
• Responsible for data integrity
• Preparation and participation in inspection to obtain a GMP manufacturing permit according to PIC/S
• Training of employees: QM system and DMS system according to GMP
• Qualification of devices and plants according to GMP
• Qualification of an incubator production plant
• Process validations
• Validation of plant and device software, including connected infrastructure
• Qualification of contract manufacturers, suppliers (incl. IT) and testing laboratories, according to GMP (including audits)
• Project management

• Support of the responsible person GDP
• Implementation of electronic SOP management system
• Computer system validation (SOP management system)
• Project participation for the serialization of pharmaceuticals (securPharm)
• Preparation and CAP analysis for the implementation of the GDP guideline
• Project support and management for the conversion to temperature-controlled drug transports
• Contact person for logistics service providers (storage and transport of medicines)
• Carrying out self-inspections in the areas: pharmaceutical quality complaints, global logistics
• Development, establishment and implementation of extended quality management: change control, variances, CAPA processes, risk management
• Revising and rebuilding SOPs
• Performance of the role QVC, quality validation compliance of the internal SAP solution COMET
• Preparation and planning for the introduction of the CCM system (cold chain management)
• Participation in due diligence audits on behalf of the responsible person GDP in several 3PLs

• Redesigning the quality management manual
• Revision and creation of SOPs
• Prepare training courses
• Preparing an official inspection for wholesale approval
• Conceptual support for pharmaceutical quality assurance (complaints/recalls)
• Preparation of internal audits

• Restructuring of the existing QM system
• Creation of the quality management manual
• Creating SOPs
• Conduct training
• Preparation for inspection to obtain a wholesale license according to §52a AMG
• Participation at inspection by the government of Tübingen (wholesale license granted)
• Preparation and execution of audits at the assembler and supplier
• Project management

• Consulting and project work: process and quality management
• Construction of aseptic production unit
• Establishment of quality assurance according to GMP
• Establishment of process chain biological drugs according to GMP
• Implementation of document and data management solution according to GMP, including data integrity
• Preparation and participation at inspection to obtain a GMP manufacturing license according to AMG
• Training of employees: QM system and DMS system according to GMP
• Validation DMS system according to GMP
• Administration of DMS system
• Qualification of equipment and plants according to GMP
• Process validation according to GMP
• Computer system validation (CSV)
• Preparation of approval dossiers
• Auditing of contract manufacturers, suppliers (incl. IT) and testing laboratories, according to GMP
• Carrying out self-inspections
• Project management

• Concept development for the FLUGS information service and internal knowledge management
• Analysis actual state of FLUGS information service
• Analysis actual state knowledge management processes
• Analysis of the IT processes involved evaluation and concept development project

• Support and implementation of quality management according to GCP
• SOP administration (write and manage)
• GxP audit at software supplier and supplier
• Supervision of self-inspections

• Concept development for a product lifecycle management solution based on the basics of GXP and the requirements of the FDA (21 CFR Part 11)
• Modules for GLP, GMP, GCP, and eCTD

• Preparation of specification, qualification documentation (encapsulation machine)
• Specifications, risk assessment, qualification report
• Illustration of GLP, GMP processes for process control and documentation software
• Actual analysis of existing quality systems and processes
• Development of a concept for mapping the processes for GLP, GMP
• Creation of a decision matrix (system)
• Risk assessment of processes, implementation
• Mapping of all processes according to GLP, GMP
• Documentation of processes and work steps

Former Managing Director.

• Structure, architecture of an oncological data warehouse
• Data acquisition, cleaning, plausibility check, structuring, processing of clinical data (GCP)
• Risk assessment, validation of data sets and processes
• Data analysis (SAS warehouse tools)

Senior Employee.

Employee.