R.D. McDowall

R.C. McDowall is the principle of McDowall Consulting and director of R.D. McDowall Limited, and "Questions of Quality" column editor for LCGC Europe, Spectroscopy's sister magazine.


Guess Who’s Coming to Inspect R&D?

September 01, 2023

The publication of a new FDA compliance policy for pre-approval inspections (PAIs) introduces a new objective to inspect research and development in pharmaceutical development. We explore how this could influence the PAI process now.

Do You Really Understand the Cost of Noncompliance?

November 01, 2020

Two recent warning letters show that the US FDA is substantially increasing the amount of remediation work it requires for companies to correct data integrity noncompliance. That work can be very expensive—far exceeding the cost of ensuring compliance in the first place.

Spreadsheets: A Sound Foundation for a Lack of Data Integrity?

September 01, 2020

Spreadsheets are often used to perform GMP-related calculations, but can lead to serious problems and unnecessary risk. We explain why the use of spreadsheets is heavily discouraged in a regulated laboratory environment.

Do You Understand the FDA’s Updated Approach to Pre-Approval Inspections?

December 01, 2019

The Food and Drug Administration (FDA) has issued an updated version of its Compliance Policy Guide for Pre-Approval Inspections (PAI). This article will guide you on this policy’s impact on analytical procedures and data included within regulatory submissions.