ASEPTIC SERVICES FOR MANAGERS (ASFM) Tuesday 12 – Wednesday 13 May 2015 DAY ONE – Tuesday 12 May 2015 Chair: Peter Rhodes, Principal Pharmacist Quality Assurance, University Hospital Southampton NHSFT, Past Chair of the NHS Pharmaceutical Aseptic Services Group 09.30 Registration and coffee 10.00 Welcome and introduction to day one Peter Rhodes 10.15 Current issues and priorities for the aseptic service manager Peter Rhodes 10.50 The responsive aseptic service meeting clinical needs Nicolas Wake, Lead clinical pharmacist for patient safety, governance and aseptics at Northumbria Healthcare NHS Foundation Trust 11.30 WORKSHOP: Current problems and issues for the aseptic manager Peter Rhodes and David Lovett, Principal Pharmacist - Aseptic Services and Clinical Trials, University Hospitals of Leicester (coffee/tea to be taken during workshop) 12.00 Workshop feedback session 12.30 Lunch PARALLEL SESSIONS: 13.30 – 14.10 Parallel session (a) Motivation Suite Parallel session (b) Energy Suite Training and developing your aseptic Practical aspects of capacity and workforce contingency planning Rachael Whiteley, Maedeh Bigdeli Soltani Aseptic Services Lead, Production Manager, Royal United Hospital Bath Barts Health NHS Trust Room: Motivation suite (capacity 80) Room: Energy suite (capacity 70) 14.10 – 15.00 Parallel session (c) Motivation Suite Parallel session (d) Energy Suite Good practice and risk management The design, construction and with paediatric PN compounding operation of cost-effective clean Paul Tunstell, Pharmacy Aseptic rooms Richard Fagg, Clean Air Technology Services Manager, Guy's & St Thomas' NHS Foundation Trust Room: Motivation suite (capacity 80) Room: Energy suite (capacity 70) 15.00 Tea 15.15 Risk management and learning from errors in aseptic units Richard Bateman, QA Specialist Pharmacist, Guy’s Hospital 16.15 Biologicals – practical considerations with handling and storage Andrew Watts, University of Bath 17.15 End of day one 18.45 Coach departs village hotel for course dinner 19.00 Course dinner – Sous le Nez restaurant 1 DAY TWO - Wednesday 13 May 2015 Chair: Peter Rhodes, NHS Pharmaceutical Aseptic Services Group 09.00 Introduction to day two Peter Rhodes, Course Director 09.05 Microbiological issues in Aseptic Services John Rhodes, Laboratory Manager, Stockton Quality Control Laboratory 09.45 WORKSHOP & Environmental control clinic Clean-room Environment issues for managers John Rhodes, Laboratory Manager, Stockton Quality Control Laboratory 10.35 Coffee PARALLEL SESSIONS: 11.00 – 11.45 Parallel session (a) Motivation Parallel session (b) Energy Quality Management in the production Managing hazards for operators of pharmaceuticals – Developing a Rachael Whiteley, Aseptic Services Lead, quality system for aseptic services Royal United Hospital Bath and Hosea Litiku, Teresa Morris, Senior QA, Quality Assurance Manager Royal United Hospital Bath Royal Devon and Exeter NHS Trust Room: Motivation suite (capacity 80) Room: Energy suite (capacity 70) 11.45 – 12.30 Parallel session (c) Motivation Suite Parallel session (d) Energy Suite Preparing for EL(97)52 Audits and Presenting products in the 21st century MHRA inspections – vital tips and – labelling for patient safety – new title guidance for service leads at all TBC levels. Alex Bosley, David Lovett, Principal Pharmacist Specialist QA Pharmacist and former Aseptic Services and Clinical Trials, Aseptic Service Manager, Cardiff and Vale University Hospitals of Leicester University Health Board Room: Motivation suite (capacity 80) Room: Energy suite (capacity 70) 12.30 – 13.00 Parallel session (e) Motivation Suite Parallel session (f) Energy Suite Recent developments in standards, Validation strategies for aseptic guidance and legislation services Peter Rhodes, Principal Pharmacist Mark Oldcorne, All Wales Director of Quality Assurance, University Hospital Pharmaceutical Quality Assurance, Southampton NHS Foundation Trust Cardiff & Vale University Health Board Room: Motivation suite (capacity 80) 13.00 14.00 14.45 15.45 16.00 Room: Energy suite (capacity 70) Lunch Corrective Action & Preventative Action (CAPA) Speaker to be confirmed WORKSHOP: CAPA Lead by Peter Rhodes and Tim Sizer (coffee/tea to be taken during workshop) Workshop feedback session The future for aseptics Tim Sizer, Regional Pharmaceutical Quality Assurance Officer – NHS South West 16.35 End of day two and course, issue of certificates Please note that, although the organisers remain devoted to the programme specified, they reserve the right to vary the programme in detail if required to do so by factors beyond their control. 2 3