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Detailed Management Committee Page
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Welcome to the Management Committee Page

Here you will find more details on the management committee, contact information and a short biography.

 

James Drinkwater

Position: Chairman

Email: jamesdrinkwater@phss.co.uk

Biography: 

James Drinkwater is the Head of Aseptic processing technologies and GMP compliance at F Ziel Germany. James has the role as Chairman of the and leader of the PHSS Bio-contamination and RABS special interest groups. James is also an active member of the PDA and ISPE.

Having worked 10 years in the Pharmaceutical industry, Amersham UK now GE Healthcare this was followed by positions of Technical Director at Barrier technology companies and Process and Compliance Director at a Bio-decontamination company. James is a subject matter expert (SME) on Gaseous disinfection and surface sterilisation using Hydrogen peroxide vapour (VH202) technologies together with associated biological indicators with contribution to the PDA technical report 51 on BIs for gaseous decontamination processes.

James current specialisation is in the area Aseptic processing for sterile product manufacturing, filling and sterility testing, working actively on projects providing support in process design, control strategies, risk based process monitoring for solutions in contamination and cross contamination control together with GMP compliance.

 

Jenni Tranter

Position: Vice Chairperson

Email: jenni.tranter@synergyhealthplc.com

Biography:

Jenni joined the Management Committee of PHSS in November 2013, bringing 17 years experience working in Healthcare and Medical Industries and became Vice Chair of PHSS in July 2015. Jenni graduated from UWIC in 1998 with BA(Hons) in Business Management and worked for Healthcare manufacturers prior to joining Synergy Health in May 2003, as a Regional Sales Manager, then in 2009 became Marketing Communications Manager before moving into her current role in 2013.  In her role as Business Development Manager for the Applied Sterilisation Technology Division of Synergy Health Jenni is responsible for generating new business, promoting market initiatives, and coordinating research projects across Europe. She achieves this partly through organising and overseeing training and educational events.  Commenting on how her involvement with PHSS supports this aspect of her professional role Jenni said: “PHSS brings together the health care and life sciences sectors and offers a vast range of knowledge and expertise. “My PHSS membership and involvement support the training packages we provide, ensuring they are of educational benefit. Since my professional role involves the coordination of training events I am delighted to support the Society in developing its latest series of webinars.” The connections that members are able to make through the Society are also a major benefit. Highlighting this Jenni said: “The PHSS attracts the best thought leadership and opinion influencers in our industry. Emphasising the not-for-profit status of the Society Jenni said: “The PHSS’ focus is entirely on its members, delivering the service its membership requires. The membership fee is incredibly good value given the resources, information, events and networking opportunities that PHSS provides. “PHSS is the go-to Society for assistance with the challenges associated with regulatory change and manufacturing - without trying to sell you anything.”

 

Simon McEwen

Position: Treasurer

Email: simonmcewen@phss.co.uk

Biography:

Simon joined PHSS when it was still the Parenteral Society in 2002. He has served on the Management Committee since 2004, and has been Treasurer since 2006.

Simon worked for ITH Pharma Ltd as their Quality Manager, responsible for product deviations, customer complaints, change control and the company’s standard operating procedures.

Commenting on his motivation to join the Society Simon said: “Back in 2002 I attended a meeting organised by the Parenteral Society to discuss a revision to Annex 1 of the Orange Guide with its author, an MHRA inspector. There were 120 delegates in attendance and at the time it was clear to the profession that contemporary technology could not support the new regulations that were being put forward. As a result of the meeting the revision was rewritten.

“The PHSS played a central role in putting right a revision to an important piece of guidance that went wrong. This seemed to me to be an excellent reason to be part of the Society.”

For Simon the three most helpful aspects of PHSS membership are the monthly regulatory updates, the opportunities to meet like-minded individuals in the same industry and share best practice approaches, and the ability to tap into a wealth of expertise to help solve problems.

“There are limited time and resources in our profession to attend lots of meetings to keep up-to-date with regulatory change, so it is terribly useful to receive regular highlights of the rule changes.

“There have also been about three occasions where I have been able to appeal to the membership with a question I couldn’t answer for myself, and received very useful responses from others in the profession.”

Going forward Simon sees the PHSS continuing to play an influential role in improving the dialogue between the regulators and the industry. He said: “Thanks to PHSS there are more industry professionals involved in the current process to revise Annex 1.

“This forum is crucial for the industry to work together to find solutions to troublesome aspects of Good Manufacturing Practice.

“Companies often don’t see the value of sharing best practice, but it is always better to identify problems before they happen. The PHSS is a great enabler of this.”

 

 

Eric Dewhurst

MC Member

Email:  ericdewhurst@phss.co.uk

Biography:

For the past six years Eric has been an Aseptic Processing Fellow with the Sterility Assurance Group of healthcare and pharmaceutical giant Johnson and Johnson. His responsibilities include regulatory outreach, standards development, training, mentoring, and technical support. He has been a member of PHSS since the late 1980s, and has recently returned to the Management Committee after his first stint in the early 1990s.

Eric perceives huge value in PHSS’ role as a bridge between industry and regulation. He said: “The non-commercial and highly technical approach that PHSS takes is very influential with regulatory bodies and means that industry concerns can be fairly and impartially represented. PHSS allows companies to be part of the regulatory debate without the interference of commercial interests.”

In his J&J role Eric often has to carry out technical reviews and finds the monographs produced by the PHSS exceedingly useful. He said: “I frequently revisit back issues of the monographs to research developments and cross-check against current thinking. The membership fee is great value for access to the monographs alone.”

Commenting on the main benefits of the Society Eric said: “In my early career PHSS enabled me to build contacts with some very well-established people in the industry, and for start-up companies these days this can continue to be a beneficial aspect of membership.

“It’s also great that PHSS attracts MHRA speakers to its events. This gives industry professionals the opportunity to connect with regulators both formally and informally.”

Eric is pleased with the recent move to produce Impact Statements in response to regulatory changes, and sees these as particularly helpful to smaller companies who may not have the infrastructure to follow all the changes going on. He said: “Expectations are now very clearly focussed, not on ’are you aware of the change?’ but on ’what have you done about it?’

“The Impact Statements can be of huge value in terms of time, resources and compliance.”

 

Commenting on the future of PHSS Eric said: “PHSS will play two key roles moving forward: firstly, in providing an impartial and well respected voice on technical and regulatory issues.

“Secondly in supporting and serving the needs of the individual. Many of the next generation of industry professionals will not be starting out in big companies and won’t have the internal opportunities to learn and develop as many of my generation did. The growth of smaller companies and the increase in the number of professionals working on short term contracts means The Society is the place for them to find key technical information, make career long contacts and share best practice.” 

 

Lindsay Dick

MC Member

Email: lindsaydick@phss.co.uk

Biography: 

Dr Lindsay Dick is currently Head of Production for Cancer Research UK Formulation Unit based at the University of Strathclyde. She has more than 15 years of pharmaceutical industry experience initially specializing in drug formulation. For the last 10 years she has concentrated on the manufacture of both sterile and non sterile dosage forms for Phase I and II clinical trials.

Dr Lindsay Dick has been a Member of the PHSS for 6 years. She qualified as a pharmacist from University of Strathclyde, which was followed by a PhD in Pharmaceutics also from the University of Strathclyde. She is a member of a number of scientific professional bodies including the Royal Pharmaceutical Society of Great Britain and the General Pharmaceutical Council.

 

Alan Heavey

MC Member

Email: alan@sterilizationsolutions.co.uk

Biography:

Alan is a Consultant Sterilizing Engineer registered by the Institute of Healthcare Engineering and Estate Management (IHEEM), originally as an Authorised Person (Sterilizers) and now as an Authorising Engineer (Decontamination).  He has over 35 years of ‘hands-on ‘experience in the field of steam and dry heat sterilization as a consultant and trainer within the Pharmaceutical, Biotechnology and the Medical Device industry.  Alan operates internationally and constantly seeks to ensure an understanding of good science and ‘sound reasoning’ as a basis to meeting GMP to ensure a quality product, in an area of increasing regulatory concern.

 

Malcolm Holmes

MC Member and author of Monthly Regulatory Update

Email: malcolmbrian.holmes@tiscali.co.uk

Biography:

Malcolm is a Chartered Chemist, a Member of the Royal Society of Chemistry and eligible as a UK Qualified Persons Register. He joined the management committee of PHSS in November 2013 and is the author of monthly and quarterly Regulatory Updates for members and a contributor to the biocontamination monograph. He is also a member of International Society for Pharmaceutical Engineering (ISPE) and was a co-author of the ISPE RiskMaPP (ISPE Committee of the year award 2010). As well as these activities, Malcolm is also a member of the Advisory Panel of the magazine GMP Review.

He has international experience having worked for GSK in Iran, Italy, New Zealand, and Spain over a period of more than 10 years. He spent many years in senior positions in the GSK Corporate Quality Directorate, during which time he was an active member of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Manufacturing and GMP Committee, leading the EFPIA Topic Teams for Mutual Recognition Agreements / Regulatory Inspections /ICH Q9 (Quality Risk Management) for which he received a USFDA “Levering Collaboration Award 2011”

Since retirement after 41 years with Glaxosmithkline, Malcolm maintains an active interest in the pharmaceutical industry and its regulation. He provides ad hoc consultancy and training within the industry and professional bodies and is a part time lecturer to the Faculty of Pharmacy at Brighton University (UK) to Post graduate QP students.  He has had extensive exposure to the Global aspects of the business and the changing global regulatory climate.

 

Di Morris

MC Member

Email: dimorris@phss.co.uk

Biography:

Di Morris  - MRSC Chemistry and PGDiPS and a Qualified Person under permanent provisions since 1993; who has worked in the pharmaceutical industry for over 30 years, a number of years as a Medicines Inspector for the MHRA. Di has worked in the areas of Quality Control (Chemistry and Microbiology), Quality Assurance and Regulatory Affairs and worked with a wide range of dosage forms including sterile products, biological, and non-sterile products. Di now works for GSK in the Compliance Audit Group.

 

Kay O'Hagan

MC Member and Editor in Chief

Email:  kayohagan@phss.co.uk

Biography:

Kay joined the Parenteral Society in the early 1990s and has served on the PHSS committee for almost a decade. Her professional responsibilities in Quality Control for Hospira make her involvement with PHSS crucial to her success and that of her organisation.

Explaining the value of her PHSS membership Kay said: “It’s the best way for me to keep up-to-date with best practice regulations and changes.

“Thanks to the admirable energy and drive of our Chairman James Drinkwater the technical monographs have been given a new lease of life. These are critical documents in sharing knowledge and expertise within our industry and the PHSS is the only place where they can be found.”

A major benefit of PHSS in Kay’s eyes is the networking opportunity it provides.

“This was especially important when I started work in Wales for PCI,” Kay said. “There were lots of small science-based and bio-tech companies based in the region, but there were no opportunities locally for Continued Professional Development. Qualified Persons need to make a register of  their CPD available to the MHRA , but industry professionals had to take themselves to London for events, which was proving time-consuming, costly and ineffective.”

So under the PHSS Special Interest Group umbrella Kay established the Welsh Qualified Persons’ Forum.  “Initially we organised quarterly meetings but this has now become an annual conference,” Kay said.

“It is a small and productive gathering. Focussing on local companies it is an excellent network for the Welsh pharmaceutical industry, which the Welsh Government is keen to promote.

“As a result opportunities have arisen for greater association with Welsh universities to offer courses in pharmaceutical GMP, bringing local companies closer to the academic R & D community.”

Commenting on the importance of conferences in the PHSS calendar Kay said: “They make it easy to meet people outside work with the same issues as you are dealing with. You can discuss concepts and approaches and different ways of doing things. It gives you confidence to know that you’re doing things properly; and guidance when you need to know how to tackle issues.

Talking of the significance of the PHSS Kay said: “It is very important to me and to the UK pharmaceutical industry that the Society continues to prosper and deliver the range of services currently offered.

“There’s no other way to get non-biased, objective, up-to-date information and guidance in our profession.”

 

Abdul Raji

MC Member

Email: abdulraji@phss.co.uk

Biography:

Abdul is currently employed in Hospira Aseptic Services, North London as Manufacturing QA Head. His current role includes direct support of manufacturing in the area of aseptic processes, Environmental Monitoring, GMP and developing understanding of regulatory requirements and scientific advances. Prior to this role, he had worked in other sterile manufacturing Pharmaceutical organisations such as: Porton Biopharma Ltd, GSK, Siemens Healthcare and Genzyme (Sekisui).

With about 30 years of experience practising as a microbiologist, he has been involved at various levels in process improvement & product development, providing microbiological support for operational and performance qualification of cleanrooms and other controlled environments, environmental monitoring, Quality Control and Quality Assurance and research & development in areas of both classical and molecular microbiology. He has worked in different sectors including; academia, research and development and pharmaceuticals (sterile and non- sterile).

He has also worked in a customer facing role in Cherwell Laboratories, U.K as Product Specialist. In this role, he provided technical support to customers and distributors with regards to the application of Environmental Monitoring media and processes. He is also a member of the Royal Society of Biology and presently serving as Management Committee member of PHSS.

 

Graham Steele

MC Member

Email: graham.steele@tesco.net

Graham is an experienced microbiologist. From 2002 – 2008 he was based at Albert Browne Ltd. (a subsidiary of  Steris UK), where he was employed as a Consultant Microbiologist working on the development of biological indicators displaying high standards of reproducibility for use in sporicidal vapour-phase decontamination cycles and a range of sterilization processes.  He was Head of the Department of Biomedical Sciences at the University of Luton (now University of Bedfordshire) until 2002, when he left to develop his role as an independent consultant to the pharmaceutical and medical device manufacturing industries in the areas of sterilization and contamination control. Having over 35 years’ experience in higher education, lecturing on a wide range of subjects in the field of microbiology. 

Graham has been involved in British Standards Institute Subcommittees and involved in working parties for Technical Report Publications. 

Graham has been on the Management Committee since 2008 and has contributed to the Society.

 

Tim Triggs

MC Member

Email: timtriggs@dopsolutions.com

Biography:

Tim Triggs is currently Director of DOP Solutions Ltd, Cleanroom Equipment  Suppliers Pty Ltd and The Academy of Cleanroom Testing Ltd. His role covers technical, sales and training within the international clean air and containment industry providing testing and validation solutions, instruments and monitoring systems. Previously he worked for GlaxoSmithKline plc in a number of operations, engineering and QA roles in the UK. He has more than 20 years of cleanrooms, contamination control and pharmaceuticals operations in the areas of steriles, solid dosage, liquids and creams.

Tim has been a past member of the Parenteral Society, and more recently the PHSS. He spent more than 10years supporting the BSI committee responsible for ISO14644 and is currently a trainer for many contamination control societies and conferences. Tim is an Engineer and Pharmaceutical Scientist. 

 

Janice Wallace

MC Member

Email: janice.wallace@pharmagraph.co.uk

Biography:

Janice joined Pharmagraph in 2011 as an Applications Engineer after working as a project engineer for 5 years within the same industry sector. Her role within Pharmagraph involves working with customers on assessing and delivering particle and environmental monitoring systems for monitoring cleanrooms and controlled environments mainly in the pharma, aviation, space and life science industries.

Janice was on the working party for the PHSS Special Interest Group which produced the published guide to continuous particle monitoring to EU GMP Annex 1 from the PHSS ‘Best Practice for Particle Monitoring in Pharmaceutical Facilities’.

Janice is a member of the Institute of Engineering and Technology (IET) and PHSS. Janice has been on the IET Hereford & Worcester Management Committee since 2012 and on the PHSS Management Committee since 2008. She has actively contributed to the Society. Assisting with organising events, speakers and contributing to the Special Interest Group on Particle Monitoring, as well as regular attendance at Management Committee meetings. 



 

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