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Ken Leiper - CChem.,MRSC of Benson Associates

 

Ken Leiper of Benson Associates has 37 years experience in Pharmaceutical Quality Systems, Analytical Science and Process Analytical Technology. He has held a range of senior management positions with Glaxo/Wellcome Manufacturing in both active pharmaceutical and drug product manufacture.

Before forming Benson Associates in 1996 to provide independent consulting to the pharmaceutical industry, Ken led a group focused on the development of computer-aided chemistry systems to facilitate improved process understanding and control.

 

Over the last nine years he has continued active involvement in the evolution of manufacturing science through consultancy with major pharmaceutical companies, PAT equipment vendors and regulatory agencies:

  • supporting Process Analytical Technology (PAT) initiatives from design to regulatory approval

  • identifying technology providers capable of providing integrated solutions for such initiatives

  • stimulating and promoting dialogue between industry and major regulatory agencies in the above areas

  • as a member of the scientific advisory board of a number of innovator companies Carrying out “due diligence” reports for venture capital investors

He was also a member of The British Pharmacopoeia Committee E - Antibiotics and The European Pharmacopoeia Committee 10C – Synthetic Products.

Externally he has been involved in the establishment of:

  • Centre of Process Analytics and Control Technology

  • The London School of Pharmacy NIR Centre of Excellence

  • The Royal Pharmaceutical Society’s New Technology Forum

  • FDA’s PAT initiative as an invited member of the steering group

  • ASTM Committee E55 - Pharmaceutical Application of Process Analytical Technology

  • European Pharmaceutical Review as Editor

His expertise in the PAT area is widely recognised as a regular contributor, programme coordinator and chair of national and international meetings on the topic held by the following organisations:

  • American Association of Pharmaceutical Scientists

  • International Society for Pharmaceutical Engineering

  • FDA’s Current Series of International PAT Forums

  • FIP

  • International Forum on Process Analytical Technology

  • Royal Pharmaceutical Society

Ken's other interests include:

  • The Royal Society of Chemistry Automation and Analytical Management Group

  • In 1989 he was a member or the RSC Analytical Division Working Party responsible for the report - "The Future of Analytical Science" and in consultancy he co-authored the discussion paper - “A strategic Framework for Analytical Science in the UK” commissioned by the DTI which acted as a catalyst for  the UKAP initiative.

  • The Royal Society of Chemistry/ Royal Pharmaceutical Society Joint Pharmaceutical Analysis Group

  • The Royal Pharmaceutical Society New Technologies Forum

  • Chair of ASTM Pharmaceutical Application of Process Analytical Technology  Committee E55.01

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Ken Leiper and Benson Associates provide specialist expertise to Btt in the pharmaceuticals industry and in advanced analytical laboratory techniques.

   
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