PHSS Aseptic Processing Training Workshop 2025 incl networking dinner

Director, Business Transformation at West Pharmaceutical Services.
I joined the West Pharmaceuticals Team in 2005, I have over 20 years of experience in Quality and Program Management. In my current role as Director Operations, PMO, I provide strategy, vision, direction and support for the Program Management Organization and I lead Strategic Global Initiatives across the Containment & Contract Manufacturing & Device Organizations in the focus areas of Program Management, Lean Six Sigma, Risk Management, Learning & Development, Intermix & EU GMP Annex 1.

Key goals & objectives are continuous improvement, standardization and harmonization across the West Pharmaceuticals global network. I enjoy collaborating with other functional disciplines within the business; specifically facilitating & establishing global best practices. I also enjoy the opportunity to collaborate & partner with our customers & suppliers.

Prior to my current role, I held a variety of positions in both Quality Systems & Compliance, Program Management NPI (New Product Introduction) at our West Pharmaceuticals Dublin facility.

I have a Bachelor of Arts (Hons) Degree in Information Systems Technology from Atlantic Technological University, Sligo, Ireland.

James Drinkwater is the Head of GMP compliance at FranzZiel Germany supporting international Pharmaceutical manufacturing/ Filling projects from a UK base. In addition James, as ex-Chairman, has an honorary membership role as Head of the PHSS Aseptic processing and Annex 1 focus groups. The PHSS – Pharmaceutical and Healthcare sciences society provide education in Good Manufacturing Practice (GMP).

James is a qualified Pharmaceutical process engineer with additional education in Pharmaceutical microbiology and an international conference speaker actively supporting the PHSS, PDA , ISPE and UK PQG (Pharmaceutical Quality Group) events. James is a lecturer on QP training courses and a qualified trainer (SME) on Barrier Separation Technology: RABS and Isolators with integrated hydrogen peroxide vapour bio-decontamination systems used in Aseptic processing.

Having worked 10 years in the Pharmaceutical industry, Amersham International 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 current specialisation at F Ziel GmbH is in the area Aseptic processing for sterile product manufacturing including biological products and ATMPs, filling and sterility testing, working actively on projects providing support in process design, control strategies, risk based process control and monitoring for solutions in contamination and cross contamination control together with GMP compliance.

James heads up consultancy support for a Microbiological and analytical chemistry laboratory in F Ziel Germany working on biological indicators pre-use qualifications and biocompatibility studies including Biological product compatibility with oxidising agent residuals e.g.H202.

Experienced in contamination control primarily for pharmaceutical, Biotech and industrial customers.

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, Compliance Audit and worked with a wide range of dosage forms including sterile products,biological, and non-sterile products. Di now works for PNR Pharma as a Qualified Person/QA Compliance Advisor. Di has been on the PHSS Management Committee for 8years and was an integral part of the recent consultation process representing the PHSS for the Annex 1 revision. Di is Vice-Chair for PHSS.

Janice has worked as an Applications Engineer and project engineer for the past 16 years within the pharmaceutical and healthcare sector. Her role within Pharmagraph involves working with customers on assessing and delivering particle and environmental monitoring systems for monitoring cleanrooms and controlled environments, with a commitment to compliance, technical proficiency, and effective support of the industry through regulatory changes 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, having currently held the position of Treasurer for the past 8 years. She actively contributes to the Society, having acquired a comprehensive working knowledge of Industry Bodies / Professional Membership, EU-GMP and cGMP guidelines, particularly in clean room monitoring applications within the pharmaceutical sector.