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 innovative 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 the development, implementation and maintenance of a quality management system (modelled on ISO 900X, EU/GxP etc.), and later – in my capacity as DPO/GDPR Specialist, a full GDPR compliance-package (modelled on ISO 2700X/27701/27799/29100).
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 ethics, 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, responsibilities, quality, confidentiality, integrity, availability, risks, controls etc.
- 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 31000/27005).
- 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 9000X/2700X 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 (KPI) 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 (digitation/automation solutions, integration of controls etc.).
- Ensuring that changes to products, processes and systems are introduced in a controlled and coordinated manner (“change control”).
- Facilitation of change processes from idea to concept – ensuring that changes to products, processes and systems are introduced in a controlled and coordinated manner.
- Preparing training programs and providing stakeholders with the required training- and awareness activities etc.
- Preparing, executing, hosting of – and follow up on internal/external/”supplier” audits, government inspections and ongoing assessment, to consolidate compliance with legal/internal requirements (IAASB, ISO 19011/27007).
- Registrating, assessing and reporting of treatments, incidents, deviations, complaints, claims etc. – incl. root cause analysis, establishing, implementing and evaluating the effect of corrective/preventive actions (CAPA)/remediation, trend analyses etc. (EU/GxP etc.).
- Preparing, concluding and maintaining of third party agreements, terms and conditions etc. (general practitioners, test laboratories, suppliers, 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 (IQ, OQ and PQ), 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, technical specifications etc. (EU/GxP, OECD, WHO).
- Coordinating/performing recall operations, post-thaw check and returns to saleable stock.
- Managing donor child requests, donor child verification, donor-donor child contact and communication etc.
- Starting up new tissue centers, donation sites etc.
- Preparing marketing and tender material.
- Ensuring compliance to codes, guidelines, standards, legal requirements, equipment specifications etc.
- Liaising with regulatory authorities (e.g. registrations, applications, license variations, reporting, hearings, notifiable diseases, scientific research and interpretation of legal requirements).