With a background in the pharmaceutical industry, contract research organisations (CROs), the Danish Medicines Agency and most recently – as a long-time Quality Manager in the fertility business, I have an extensive experience with quality management, quality systems and related legal requirements (pharmaceutical drugs, tissues and cells, assisted reproduction etc.).
I am used to document, monitor and carry out audits of all phases of a product’s or service’ life cycle and take pride in promoting a “quality” culture, that results in the behaviour, attitudes, activities and processes, that deliver value, through fulfilling the needs and expectations of customers and other relevant interested parties.
Quality management is an ongoing process of detecting and reducing/eliminating errors – and thereby improving internal practices in manufacturing, streamlining supply chain management and improving the quality of the business’ outputs and customer experience.
At its core, quality management is a business philosophy that champions the idea, that the long-term success of a company comes from customer satisfaction and loyalty. An approach I very much agree with.
LHR Consult offers the following services related to quality management, legal requirements etc.:
- Provision of advice and consultation on quality planning, quality assurance, quality control and quality improvement (e.g. EU/GxP, ICH, WHO, ISO 900X).
- Acting as Quality Responsible.
- Preparation, implementation and maintenance of quality systems/documentation, e.g. quality manual, policies and SOPs (EU/GxP, ICH, WHO, ISO 900X etc.).
- In-depth reviews and optimization of existing quality processes/systems (incl. change control management).
- Identification and implementation of “quality indicators” (KPIs).
- Implementation of document management systems (e.g. software solutions).
- Preparation, entering into- and maintenance of third party agreements with stakeholders.
- Education and training of employees and other stakeholders to achieve improvement objectives.
- Preparation, execution/hosting of- and follow up on internal/external audits (e.g. business partners) and government inspections.
- Registration, assessment and reporting of unintended incidents, adverse reactions, deviations, non-conformities, complaints etc. – incl. root cause analysis and corrective/preventive actions (CAPAs), trend analysis etc.
- Risk Management/preparation of risk assessments, impact analysis and risk minimization (e.g. EU/GxP, ICH, ISO 31000).
- Preparation and management of staff records (e.g. job description, CV, introduction plan and training logs).
- Provision of legal advice and consultation (e.g. DPSA, DMA, EU/GxP, ICH, FDA, WHO, ISO).
- Integrating improvement considerations into the development of new or modified products, services and processes.
- Liaising with regulatory authorities – related to registrations, applications, reporting etc. (e.g. DKMA, DPSA, SSI, Scientific Ethics Commitees).