We have extensive experience in Quality Management Systems, Quality Assurance, Quality Control, Regulatory Affairs and validation gained in FDA approved pharmaceutical manufacturing sites.

Dave Malpas Consulting Ltd can offer advice and assistance in the following areas:

Quality Management System Policies and SOPs (Change Control, Deviations, CAPA etc).

Plans, protocols and reports for facilities and equipment qualification, process validation and analytical method validation.

Data Integrity policies, SOPs, self inspections, Risk Assessments and periodic reviews

We can also help with User Requirement Specifications, gap analysis and audit preparation.

Click on the links above for more information.