Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
Transport Validation Exercises: A GDP Compliant Approach
The Importance of Transport Validation Exercises: A GDP Compliant Approach In the pharmaceutical industry, patient safety is paramount. One critical element in ensuring that safety is maintained throughout the supply chain is the transport you use to deliver your...
Audit Planning: Tips and Tricks
Tips for Audit Planning Whether you are performing a ‘First Party’ internal audit, otherwise known as a self-inspection, a ‘Second Party’ external audit, usually relating to a supplier or customer, or a ‘Third Party’ audit, audits performed by a regulator,...
1st and 2nd Party Audit Report and Follow-up
Producing an Audit Report: What Happens Next Once you have planned and performed a first party (internal) or second party (external) audit, it is imperative that you document your findings in a formal audit report. Regulatory inspectors expect a ‘show and tell’...
Essential Guide to MHRA GDP Audits & Inspections: Preparing for MHRA Compliance
GDP Audits & Inspections To Master GDP Audits conducted by the MHRA is to achieve a level of expertise and control that ensures seamless regulatory compliance and ensures patient safety, the ultimate goal of GDP activities! MHRA Inspections are critical...