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:

• 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 [...]

• What does a Quality or technical agreement have to contain?

  19 Sep 2011 in Contract Manufacturing & GMP & Quality Agreements & Webinars

  I was on a panel discussion on Contract Manufacturing in Berlin this last week and the topic of Quality or Technical Agreements produced a vigorous debate. While everybody agreed that the requirements for the documents are codified in the EU by regulations, the FDA does not directly require them by law. However, as most know, if you [...]

• So when do you start Quality by Design?

  12 Sep 2011 in Clinical Manufacturing & Commercial Manufacturing & GMP & Quality by Design

  After participating on a panel discussion at an IBC conference on Quality by Design (QbD) and the new Process Validation guidance issued earlier this year by FDA, I was approached by a process development scientist who asked my advise on the value of implementing  QbD in their company. He explained that his company was extremely small and did [...]