|International expertise for in-house customised technical and management skill training, and quality assurance audit for Pharmaceutical, Biotechnology, Medical Device and Healthcare organisations.|
GCP Quality Assurance Audits
Laura Brown QA and Training Development. provides a full range of independent GCP Quality Assurance audits internationally and “mock” inspections in compliance with ICH GCP and applicable regulatory requirements. Dr Brown is a member of the Research Quality Association, RQA (http://www.therqa.com/) and Honorary member of the Institute of Clinical Research, ICR (http://www.icr-global.org/).
QA Services cover all aspects of GCP which are customised to meet each individual client’s needs and include:
Systems audits to assess whether a particular activity is in compliance with GCP applicable regulations and guidelines. Systems audits involve a review of the SOPs and other procedures in use, interviews of personnel carrying out the procedures.
Review of Standard Operating Procedures
Advice and preparation of SOPs to assure compliance with GCP requirements.
Audits of CROs/Vendors/third party service providers
The sponsor is responsible for demonstrating oversight of vendors and to ensure that vendors deliver to the required GCP standard. Sponsors must audit GCP vendors before a contract is in place and at regular intervals to ensure that the vendor’s systems continue to meet the regulatory standards.
Investigator site audits
Review of both Sponsor in-house and study site documentation to assure compliance with ICH GCP and all appropriate regulations is offered. Study site-specific problems can be identified and corrected, and also systematic issues that can impact on the quality of the trial as a whole can be identified.
Phase I audits
Audits of Phase I units to assure compliance with the appropriate guidelines and regulations prior to placement of study.
Preparation for Regulatory Inspections
Mock inspections are available in accordance with ICH GCP and other regulatory requirements such as the Clinical Trial Directive 2001/20/EC and FDA requirements.
Clinical Laboratory Audits
Audits of central and local laboratories ca be carried out to give assurance that they are working to GCP Laboratory Practice standards.
Standard and specifically designed courses to provide GCP refresher and update training. Training in auditing skills for new auditors and refresher courses are also available.
GCP Advice internationally
Advice on issues relating to GCP and running clinical trials internationally.
To find out more about any of these services or to discuss how we can help you, please contact Laura Brown at firstname.lastname@example.org.