Auburn Klein Consulting was founded in 2016 to provide expert consulting services in the pharmaceutical industry. The company was founded by Hannah Lloyd, who had built a wealth of expertise in relation to Quality Assurance (QA) and Quality Management activities across multiple GxP disciplines, including Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and Good Clinical Laboratory Practice (GCLP).
Since the company’s formation, Auburn Klein Consulting have worked on several short-term and long-term engagements, providing services to pharmaceutical companies.
Providing Quality Service
Examples of our completed services have included:
- Development of e-Learning training materials for process and system training.
- Development and delivery of classroom training sessions.
- Execution of audits across the following GxP disciplines; Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and Good Clinical Laboratory Practice (GCLP).
- Audits have included, clinical trial sites (Phase 1 – 3), Contract Research Organisations (CROs), clinical laboratories, contract laboratories, drug product manufacturers and clinical trial packaging and logistics providers.
- Audits have been performed worldwide, as well as remotely.
- Process audits of Quality Assurance (QA) organisational units.
- Fulfilment of Validation Manager activities for computer system deployments.
- Procedural Document (PD) / Standard Operation Procedure (SOP) development activities.
- Information Technology (IT) Project Management activities for the deployment of IT Quality Management Systems.
- SOP development covering a wide range of processes including, but not limited to, business operations of IT systems, managing IT system updates/upgrades, quality management processes such as auditing, deviation management, qualification of suppliers and vendors, training, and training curriculum maintenance.
- Short term Quality Assurance (QA) support covering staff absences.
- Development of user manuals and handbooks for IT systems.