Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
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’...
Self-inspections (First-Party Audits)
The Importance of Self-Inspections, also referred to as ‘First Party Audits’ If you are a wholesale distributor of medicinal products, you need to comply with the Good Distribution Practice (GDP) guidelines issued by the European Commission and the...
What is a WDA (H) (Wholesale Distribution Authorisation)?
WDA (H) Explained Being in possession of a Wholesale Dealers Authorisation WDA, is a legal requirement for any company that procures, stores or distributes human or veterinary medicines in the UK. , which is the UK Competent Authority responsible for ensuring the...
Inspections and Audits
Inspections and Audits – an Introduction Self-Inspection Audits, External Audits and Regulatory Inspections are crucial to finding whether there are any deviations, deficiencies, risks, or failures (or potential ones) within your company’s and your supplier’s...