Peter Calcott

A native of the UK, Dr. Calcott has a career spanning 4 decades and has worked for Pharma companies such as SmithKline Beecham, Monsanto and Bayer as well as biotechnology companies such as Immunex, Chiron and PDL. He has held positions in R&D, Manufacturing, QA & QC, Process Development, Corporate Compliance, Business Development, and Government Affairs. He has worked on biologics (vaccines, recombinant proteins, monoclonal antibodies, blood products), drugs and generics from early development to commercial. Prior to entering industry he taught at university. He is a member of the Board for BayBio and is chairman of the RAC committee of BIO. Dr. Calcott has a BS from University of East Anglia and D.Phil from University of Sussex in the UK. While in Academia he was a consultant to University, government and industry. He has published over 90 research articles, reviews and books.

Posts by Peter Calcott:

• FDA Issues New Position Paper on Quality Management Maturity

  06 Dec 2023 in News

  As FDA moves towards rewarding companies with superior quality programs, they issued a position paper to help industry. A five minute read is referenced here that I wrote about it https://www.outsourcedpharma.com/doc/fda-introduces-quality-management-maturity-program-0001

• New FDA Guidance issued on Remote Evaluations

  06 Dec 2023 in News

  With the inroduction of a new FDA guidance, I penned a short article. Its a 5 min read. Enjoy https://www.outsourcedpharma.com/doc/fda-issues-draft-guidance-on-remote-interactive-evaluations-of-drug-manufacturing-and-bioresearch-monitoring-facilities-0001

• The dilemma of getting consultants to write your SOPs for you. Should you or shouldn’t you?

  13 Aug 2019 in audits & Commercial Manufacturing & Contract Manufacturing & GMP & inspections & News & Quality Management Systems

  As a consultant, I am often brought in to assess systems, perform gap analyses or to audit. In many respects it is the same activity. I look at what is in place in the form of documents (SOPs and policies) and in processes in action in their operations. Some of these clients are large pharma […]

• The third Part of our series on QbD and Quality Continuous Improvment

  24 Sep 2017 in Commercial Manufacturing & Contract Manufacturing & FDA Guidance & GMP & News & Process Validation & Quality by Design & Quality Management Systems & Risk Management

  We are happy to announce the publication of the third part of our series.  This article, co-authored with colleagues Dr. Ko and Dr. Stein covers how to create a sustainable continuous improvement program with an emphasis on QbD.  Happy reading.  The link is https://www.pharmaceuticalonline.com/doc/how-to-catalyze-sustain-continuous-improvement-in-pharmaceutical-operations-0001   

• Part II of article “Big Data & Leadership Strategies For Enabling Quality By Design”

  29 Aug 2017 in Commercial Manufacturing & Contract Manufacturing & FDA Guidance & GMP & News & Process Validation & Quality by Design & Quality Management Systems

  Part 2 of a series of articles about Pharma implementation of new regulations and quality systems is out and available for viewing at a number of sites including Pharmaceuticalonline.com  Happy reading.