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:
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
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.
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 Management03 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
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 […]