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:

• The second part to our survey on implementation of Guidances on Company QMS

  03 Jul 2017 in Commercial Manufacturing & FDA Guidance & GMP & inspections & Process Validation & Quality by Design & Quality Management Systems & Risk Management

  In the first article dealing with our surveys, we concluded that not all of the guidances issued had been implemented completely.  Even when they had been implemented, the implementation did not take advantage of all the potential.  For instance many companies were reluctant to  not work on certain technical areas even though their risk analysis indicated […]

• New article about Implementing QbD with leverage from the two enablers, Knowledge Management and Quality Risk Management

  03 Jul 2017 in Commercial Manufacturing & News & Process Validation & Quality by Design & Risk Management

  In a recent article we presented data showing that QbD has been difficult to implement. This new articles teases apart the issues based on public data and interpretation. Enjoy the read. The link is here

• How well has the pharma industry implemented regulations?

  25 Feb 2017 in audits & Clinical Manufacturing & Commercial Manufacturing & Contract Manufacturing & FDA Guidance & GMP & Process Validation & Quality Agreements & Quality by Design & Quality Management Systems & Risk Management & Webinars

  This has always been a question people ask.  As a consultant i see a slice of the industry that interacts and works with me, so I have my opinions.  However, a company that employs me may not represent the average company.  So a colleague of mine, Peiyi Ko, and I decided to conduct a survey […]

• Compounding Centers get new and more regulations

  25 Oct 2016 in FDA Guidance & GMP & inspections & News & regulatory citations & Warning Letter

  I just had an article describing the Compounding industry and what the FDA is doing about it. Here is the link.

• EMA issues new annexes and guidances

  21 Jun 2016 in Clinical Manufacturing & Commercial Manufacturing & FDA Guidance & GMP & News & Process Validation & Quality by Design & Quality Management Systems & Risk Management

  During the last few months the European Medicines Agency (EMA) has issued a series of revisions to Annexes and Guidances Specifically, the following Annex 15 – Validation and Qualification Annex 16 – Certification by a Qualified Person and Batch  Release Annex 17 – Real Time Release Testing Guidance to Industry: Guideline on process validation for the manufacture of […]