In 2012, I changed my focus from pharmaceuticals to tissues and cells, and took to up a new position as Quality Manager/Responsible Person in a dynamic and fast-growing company within the fertility industry (European Sperm Bank). Over the next eight years, I documented all business processes, and shaped the company quality/privacy framework, through development, implementation and maintenance of a quality management system (modelled on ISO 900X/2700X, EU/GxP etc.), and later – in my capacity as DPO/GDPR Specialist (DK, UK and DE), a full GDPR compliance-package (modelled on ISO 27701/900X/29100 etc.).
I have an extensive experience with all aspects of quality management related to human “tissue and cell” activities. Thus, I am used to ensuring that business processes, data, products, services and other assets, are in line with current regulatory requirements, best practices, relevant standards, customer expectations and the company’s overall strategy and business goals.
Also managing the tasks of the Responsible Person (Danish Tissue Order §4/5), I had to ensure that all licensed activities were conducted with proper regard for the regulatory framework. This covered traceability, consents and contracting, tissue establishment permits, employee qualifications and training, record keeping, reporting and submissions, quality assurance, as well as processes such as procurement, testing, processing, storage, distribution, export and import etc.
With a head full of good ideas, application of well-thought-through solutions, and a long-standing knowledge on how to generate value through innovation and creativity, LHR Consult offers the following services:
- Providing professional expertise and guidance on tissues and cells activities such as procurement, analysis, processing, qualification, coding, preservation, storage, release, sale, distribution/export, import, recall, genetic matching, assisted reproduction, scientific research etc. (DPSA, DHA, SSI, NVK, HFEA, BGV, ECDC, EU/GxP, OECD, WHO etc.).
- Providing legal advice on patient rights, healthcare professionals’ duties/rights, authorization, record keeping, reporting obligations etc.
- Acting as Responsible Person (Tissue Order §4/5).
- Mapping of data/dataflows, systems, processes, risks, information security controls etc.
- Defining and deploying of a data quality/data governance framework (securing confidentiality, integrity, availability etc.), to ensure better data analytics, decision making, operations support and mitigate ambiguity and misuse (ISO 8000).
- Planning, implementing and driving the processes of risk management incl. identification, monitoring, performing of qualitative/quantitative analyses and risk reports, controlling – and proactively developing risk mitigation actions regarding cross contamination, mix-up’s etc. (EU/GxP, ICH, ISO 27005/31000).
- Preparing, implementing and operating quality management systems/documentation within all aspects of regulatory compliance, e.g. code of conduct, contingency plan, quality manual, policies and SOPs (EU/GxP, ICH, ISO 2700X/900X etc.).
- Setting up electronic document management systems (EDMS) for managing the creation, organizing, filing and accessing, using, sharing, controlling and securing etc. of company documents.
- Determining, measuring, analyzing, evaluating and monitoring of metrics and key/quality indicators (KPIs) to demonstrate performance.
- Managing of integrated business processes across the supply chain (supply chain management).
- Identifying and managing challenges and opportunities incl. optimizing of processes/systems according to annual compliance schedule, change requests etc., through digitation/automation solutions, integration of controls etc. (e.g. biometrics, digital photo match and compliance software).
- Ensuring that initial and continuous training programs are implemented and maintained – and providing stakeholders with the required resources, training, awareness activities and authority.
- Preparing, executing, hosting of – and follow up on internal/external audits, government inspections and ongoing assessment, to consolidate compliance with legal/internal requirements (ISO 19011/27007).
- Registrating, assessing and reporting of incidents, deviations, complaints etc. – incl. root cause analysis, establishing, implementing and evaluating the effect of corrective/preventive actions (CAPAs)/remediation, trend analyses etc. (EU/GxP etc.).
- Preparing, concluding and maintaining of third party agreements/contract management (general practitioners, test laboratories, fertility clinics, sperm banks etc.).
- Providing professional advice and guidance on donor application, classification, screening, enrolment, compensation, disqualification etc.
- Providing professional advice and guidance on donor sperm quality/yield (density, morphology, motility, volume, DNA fragmentation, microscopic analysis etc.), sperm wash (ICI/IUI etc.)/density gradient centrifugation and swim up, composition of cell culture media, cryopreservation, laboratory equipment/articles etc.
- Evaluating test kits, methods and results, diagnostic window periods etc.
- Monitoring threats from infectious diseases (e.g. SSI, ECDC, WHO, CDC).
- Providing expertise and guidance on safety and precautionary measures, e.g. regarding clean room facilities, air quality (particle/microbial counts etc.), aseptic/sterile production, personal protective equipment, biohazardous waste, liquid nitrogen/gas alert detectors, blood sampling, cleaning, hygiene and sanitation etc. (EU/GxP, OECD, WHO etc.).
- Calibrating, qualifying, monitoring and maintenance of laboratory/cryogenic equipment incl. reviewing and assessing of validation-, service- and inspection reports, certificates of analysis, package inserts, user manuals, accreditations etc. (EU/GxP, OECD, WHO).
- Coordinating and performing any recall operations – and approving returns to saleable stock.
- Managing donor child requests, donor-donor child contact and communication etc.
- Starting up new tissue centers, donation sites etc.
- Facilitation of change processes from idea to concept (design thinking, user involvement, etc.).
- Project management, improvement and oversight to ensure compliance to codes, standards, legal requirements, equipment specifications etc. (e.g. ISO 21500/10006).
- Liaising with regulatory authorities (e.g. registrations, applications, license variations, reporting, hearings, notifiable diseases, scientific research and interpretation of legal requirements).