ARTICLES BY PETER H. CALCOTT

• What's The Role Of Intuition When Making QRM Decisions?

  2/28/2022

  In Part 1 of this 2-part series, this author explained how to effectively set up your quality risk management (QRM) program for pharma and medical devices. In this article, he explains how to implement that program. For such a numbers-based field, there is still an important role for using your intuition to make QRM decisions.

• How To Set Up An Effective Quality Risk Management Program

  2/16/2022

  The author of this article has taught courses on quality risk management (QRM) and its implementation as well as seen it in action in many companies. This article, Part 1 of a 2-part series, shares some of his observations and lessons learned in setting up an effective QRM program.

• 9 Pitfalls To Avoid In Data Integrity in Pharmaceutical and Device Development & Operations

  9/22/2021

  The first article in this series examined 5 common misconceptions in data integrity (DI). In this article, the author now shares 9 example areas where he has seen significant DI implementation problems in pharmaceutical and medical device companies.

• 5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations

  9/15/2021

  Data integrity (DI) issues in pharma and medical devices have always been there, but in my experience as a consultant, these issues have increased in frequency more recently, thus moving them to the forefront. In this article, I explain five misconceptions about data integrity in our industry.