manufacture and distribution of medicine
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Driven by a passion and dedication to Quality, Sanjay has pursued what can only be described as a pioneering, textbook career path in Pharmaceutical Quality.
Sanjay is renowned for his practical approach in the application of GDP and GMP principles, and is able to connect very well with people all over the world. He is the founder of a very successful group on Linkedin, for Quality professionals, where people can problem solve, share views and best practices.
Now specialising in Good Distribution Practice, Sanjay presents at seminars and provides training in his area of expertise. An advocate of working cross-functionally, Sanjay has always ensured that Quality principles are always considered at the heart of key decisions, whether they be financial, legal or logistical.
Sanjay says, "Every business model is different. So there is no one-size-fits-all when it comes to quality systems. Based on a sound risk evaluation, appropriate controls can be applied to ensure patient and regulatory compliance within the business framework."
Graduating in Chemistry, Sanjay embarked on his career over 15 years ago in a leading global pharmaceutical company. Working as a laboratory analyst, he gained a solid grounding in the principles of Good Manufacturing Practice. Through his commitment to Product Safety, Quality and Efficacy, Sanjay has swiftly moved on to head Quality functions for Europe. Most recently he worked as a global auditor for GDP provisions, covering Europe, the Middle East and Australasia.
He has held positions in ethical and Biotechnology pharmaceutical companies as well as large and small generics. Sanjay has designed and implemented the entire Quality System for a European operation; streamlined processes, performed due diligence audits and contributed to vendor selection process as part of his extensive resume. He now works as Quality Director for inglasia pharma solutions and provides consulting services as well as training on behalf of inglasia.
Beginning his career in University teaching has given Peter the ability to assimilate complex information and present it in an understandable fashion. Working at both large and small companies gives Peter the appreciation of the many ways to approach and solve complex problems in the areas of pharmaceutical and biotechnology product development and commercialisation. Along with his vast experience, over 30+ years in the industry and as a consultant, enables him to present courses and material in a manner that makes learning easy and enjoyable for his audience.
Peter says, "With new products becoming more prone to improper conditions, the need for improved operations and safeguards has never been more important in the handling and distribution of pharmaceuticals".
Peter H. Calcott, Ph.D. is President and CEO, Calcott Consulting LLC which is focused on delivering solutions to pharmaceutical and biotechnology companies in the areas of corporate strategy, supply chain, quality, clinical development, regulatory affairs, corporate compliance and enterprise e-solutions. He is also a Senior Consultant with NSF-DBA LLC and an Academic Program Developer for the University of California, Berkeley’s Biotechnology and Pharmaceutics Postgraduate Programs.
Prior to this he was VP at the executive team level at PDL BioPharma where he was responsible for development and implementation of Quality & Compliance strategy across the corporation. Previous to that he was Chief Quality Officer and led the Quality and Compliance function at Chiron and Immunex Corporations and was Director of Quality Assurance for SmithKline Beecham and for Bayer for their biotechnology and biologics businesses. He has also held positions in research and development, regulatory affairs, process development and manufacturing at other major pharmaceutical companies. He has successfully licensed products in the biologics, drugs and device sectors on all 6 continents.
Dr. Calcott holds a Doctorate degree in Microbial Physiology and Biochemistry from the University of Sussex in England and completed his post-doctoral work at McGill University in Montreal, Canada. Recently, he was chair of the Regulatory Affairs committee of BIO and presently serves on the Board of BayBio, a biotechnology industry association in San Francisco. He has been a consultant for 17+ years to various governments, industries and academic institutions during his career. Dr. Calcott has authored over 80 original research papers, reviews and books.