Ardensax QA

An experienced quality consultant with broad experience across the GXPs.

-
Telephone:
Email:
Fax:
Address: 16 The Street, Saxon Street, Nr Newmarket
Postcode: CB8 9RU
Country: United Kingdom
Website: http://www.ardensax.co.uk
Membership type:Professional Individual and Corporate < 5 (£50+VAT pa)

Extensive GCP/GMP/GCLP/ISO17025 auditing, training and QMS development gained over 30 years.  Location of audits have included the EU, Eastern Europe, India, USA, Vietnam.  Eligible to act as a QP.

Available for interim contracts, GCP audits (eg investigator site, phase I, vendor, laboratory, TMF, documents), SOP and QMS development support

Laboratory Audits

Laboratory Audits

Sue is able to bring a wealth of experience to audits of clinical and bioanalytical laboratories

Interim placements to provide additional QA resource

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

Training

Training

Sue has extensive experience of designing and delivering training programmes both in-house for QA auditors and for clients

Regulatory Inspection Preparation

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

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.