Ardensax QA provides flexible and bespoke quality assurance services to pharmaceutical, biotechnology and healthcare companies.
Services offered by Principal Consultant Sue Anderton include:
Phase I Unit Audits
With more than three years experience working in the QA department of a phase I unit Sue is well qualified to perform these audits. She has audited these facilities in the UK, EU and India for clients and is familiar with dosing day as well as pre-contract or ‘during study’ audits.
During her career Sue has worked in several analytical laboratories using a wide range of instrumental techniques. The sites have complied with regulatory systems including GMP, GLP, GCLP and ISO 17025. She is able to bring this wealth of experience to audits of clinical and bioanalytical laboratories and has worked in the UK, EU, USA, India and the Far East on projects of this type.
Investigator Site Audits
Sue has carried out audits of investigator sites performing clinical trials in a range of therapeutic areas, in locations including the UK, EU, Russia, India and the USA. Projects have included individual audits as well as multiple sites within a clinical programme and on many occasions she has accompanied trainee auditors.
For many companies outsourcing is an essential part of running clinical trials. QA audits may be required prior to contracting or as part of routine oversight of the vendor. Sue has experience of auditing vendors from ‘full service’ CROs to niche service providers.
Study Documentation Audits
Sue has extensive experience auditing documents such as protocols/plans and final reports for research including laboratory validation projects, pre-clinical studies and clinical trials. She has also audited data sets for pre-clinical and clinical study reports.
Trial Master File & Archives
Sue has performed audits of both paper based and electronic TMFs at a variety of stages in their life cycle for many clinical trials. She has attended a workshop on the subject of Migrating Paper TMFs to Electronic and has been a member of the DIA TMF Reference model working group. Sue has had management responsibilities for archives in previous roles and is able to bring this experience to auditing archives.
Interim placements to provide additional QA resource
Sue is able to provide contract resourcing and QA consultancy services, short or medium term, full or part time.
Sue has extensive experience of designing and delivering training programmes both in-house for QA auditors and for clients. Sue can provide training on the GXPs (eg GMP for IMPs, GLP & GCLP, GCP) and SOPs (including basic process mapping). She has completed a college course on the subject of ‘making presentations’
Regulatory Inspection Preparation
Sue has assisted companies preparing for regulatory inspections in a number of ways including a gap analysis of the quality management system, mock inspection, interview practice and advice, and staff training.
Quality Management System
Sue has in-depth knowledge of the building, rationalisation and streamlining of quality management systems with a keen interest in process mapping to aid this process. Her work based project as part of her diploma in research quality assurance was the implementation of electronic SOP system. She can provide assistance in a wide variety of ways including review of authoring of individual SOPs.