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:

• Metrics associated with 483’s – how some managers just don’t get it!!!

  08 Jan 2012 in audits & Commercial Manufacturing & GMP & inspections & regulatory citations & Risk Management & Warning Letter

  Earlier in my career, as head of global quality in a well known company that will remain anonymous, we had experienced a regulatory inspection that had gone quite well.  Although it was a full week with two inspectors, we had survived with 2 citations (note I do not say 483’s – so you do not know […]

• Quality by Design and the new FDA Process Validation Guidance part 2

  05 Jan 2012 in Clinical Manufacturing & Commercial Manufacturing & FDA Guidance & GMP & Process Validation & Quality by Design & Risk Management

  The second part of the article I wrote on the above topic has been issued in the December issue of BioProcessing International. Click here for the article.  Good Reading

• Quality by Design and the New FDA validation guidance

  18 Nov 2011 in FDA Guidance & GMP & Process Validation & Quality by Design

  If you following the link here, you will see an article I recently wrote on the topic.  Good reading.  If you have any questions email me at peterc@calcott-consulting.com

• Risk management – it does not have to be complicated

  18 Oct 2011 in Commercial Manufacturing & GMP & Quality by Design & Risk Management & Vendor Qualification & Webinars

  At a course I was recently teaching at the University of California, Berkeley on Biotech Pharmaceutical Quality and Compliance, the topic of how to implement the ICH Q9 was brought up.  One attendee indicated that his company had tried to implement it and had run into trouble.  They had set up a Quality Risk Management (QRM) department and […]

• Are SOP’s Your Problem?

  23 Sep 2011 in Commercial Manufacturing & GMP & Warning Letter

  I am intrigued by certain webinar companies that appear to spend a fortune on advertising.  You’ve seen their emails and half page ads. They go like this. What’s the one thing that you can control that is a disaster waiting to happen?  Those piles  of SOP’s fresh off the press that nobody knows what to […]