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:

• Tools that make you work for them rather than working for you

  05 Oct 2014 in audits & Clinical Manufacturing & Commercial Manufacturing & GMP & News & Quality Management Systems & Risk Management

  I am often called into companies to identify opportunities for improvement in processes, products and also the Quality Management System as well. These projects give an opportunity to learn how an organisation ticks, its strengths and its weaknesses. Often management initiates the process by giving me their list of systems that they believe are broken […]

• Setting the bar for quality and compliance

  05 Aug 2014 in Commercial Manufacturing & GMP & News & Quality Management Systems & Risk Management

  There appears to be a continual debate as to where we need to set the bar for quality and compliance in the Pharma industry.  There are a number of strategies I have seen over the years but they all fall into the following in reality; We will meet what the regulations tell us – no […]

• Validation and monitors in shipping

  08 Jul 2014 in News

  During a recent webinar I gave, hosted by Tungsten Shield Group, on the topic of Cold Chain storage and shipping, I was asked a question by an attendee.  It went this way: Should I validate the shipping or can I just put a temperature monitor in?  What do the regulations require? This question was interesting […]

• Putting Quality Agreements into practice

  24 Jun 2014 in Clinical Manufacturing & Commercial Manufacturing & Contract Manufacturing & FDA Guidance & GMP & News & Quality Agreements & Quality Management Systems & Vendor Qualification

  It’s been about 1 year since the FDA issued its Guidance on Contract Manufacturing.  Based on what I read in blogs and social media like LinkedIn, I am sure not all companies are really up to speed. At an IBC conference recently, I presented a paper on the guidance and putting it into practice.  It […]

• Setting sail on a voyage to discovery – creating a culture change in your operations

  06 Jun 2014 in Commercial Manufacturing & GMP & News & Quality by Design & Risk Management

  One of the clients of a colleague of mine is undergoing a culture change in their operations from the “old-style” quality to a newer style.  What do I mean by that?  The old style is characterized by the Silo mentality, the us versus them, distrust, Quality that can be characterized as a Dr. No approach.  I think […]