Pharmaceutical Technology and Quality Assurance (PTQA) School of Healthcare FACULTY OF MEDICINE AND HEALTH ASEPTIC SERVICES FOR MANAGERS (ASFM) Tuesday 21 – Wednesday 22 May 2013 DAY ONE – Tuesday 21 MAY 2013 Chair: Peter Rhodes, Chair of the NHS Pharmaceutical Aseptic Services Group 10.00 10.30 Registration and coffee Welcome and introduction to day one Peter Rhodes, Course Director 10.40 Current issues and priorities for the aseptic service manager Peter Rhodes, Principal Pharmacist Technical Services, University Hospital Southampton NHS Foundation Trust. 11.20 Clinical priorities for aseptically prepared injections Steve Williams, Consultant Pharmacist in Medicine & Medication Safety, University Hospitals of South Manchester NHS Foundation Trust 12.00 WORKSHOP: Current problems and issues for the aseptic manager Led by Peter Rhodes & Steve Parrish (Associate Director of Pharmacy, QE Hospital Birmingham), with Adam Hocking (Principal Pharmacist Quality Assurance) and Caroline Simmonite (Oncology Pharmacy Manager, both at University Hospital Southampton) (coffee/tea to be taken during workshop) 12.30 Workshop feedback session 13.00 Lunch PARALLEL SESSIONS: 14.00 – 14.40 Parallel session (a) Energy Suite Parallel session (b) Motivation Suite Practical aspects of capacity and Training and developing your aseptic contingency planning workforce Dena Godward, Assistant Chief Ellen Williams, South West Medicines Pharmacist, Technical Services at Barts Information & Training, University Hospitals Health NHS Trust Bristol NHS Foundation Trust Room: Energy suite (capacity 70) Room: Motivation suite (capacity 80) 14.40 – 15.30 Parallel session (c) Motivation Suite Parallel session (d) Energy Suite Good practice and risk management The design, construction and operation of with paediatric PN compounding cost-effective clean-rooms Paul Tunstell, Pharmacy Aseptic Richard Sutherland, Omicron Projects Ltd Services Manager, Guy's & St Thomas' NHS Foundation Trust Room: Motivation suite (capacity 80) Room: Energy suite (capacity 70) 15.30 Tea 15.45 Validation strategies for aseptic services Mark Oldcorne, Director, North Wales Pharmaceutical Quality Assurance, Betsi Cadwaladr University Health Board 16.45 Biologicals – practical considerations with handling and storage Andrew Watts, University of Bath 17.25 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 22 MAY 2013 Chair: Peter Rhodes, NHS Pharmaceutical Aseptic Services Group 09.00 09.05 09.45 10.35 Introduction to day two Peter Rhodes, Course Director Microbiological issues with aseptics John Rhodes, Laboratory Manager, Stockton Quality Control Laboratory WORKSHOP: Environmental issues for managers John Rhodes, Laboratory Manager, Stockton Quality Control Laboratory Coffee PARALLEL SESSIONS: 11.05 – 11.45 Parallel session (a) Energy Suite Investigational Medicinal Products Adam Hocking, Principal Pharmacist Quality Assurance, University Hospital Southampton Room: Energy suite (capacity 70) 11.45 – 12.45 Parallel session (c) Motivation Suite Risk management and learning from errors in aseptic units Richard Bateman, QA Specialist Pharmacist, Guy's Hospital 12.45 13.30 14.15 14.35 15.10 15.35 16.15 Parallel session (b) Motivation Suite Managing hazards for operators Caroline Simmonite, Oncology Pharmacy Manager, University Hospital Southampton Room: Motivation suite (capacity 80) Parallel session (d) Energy Suite Presenting products in the 21st century – labelling for patient safety Alex Bosley, Specialist QA Pharmacist and former Aseptic Service Manager, Cardiff and Vale University Health Board Room: Energy suite (capacity 70) Room: Motivation suite (capacity 80) Lunch Quality Management in the production of pharmaceuticals – Developing a quality system for aseptic services Adam Hocking, Principal Pharmacist Quality Assurance, University Hospital Southampton NHS Foundation Trust CAPA – Corrective Action & Preventative Action Anne Black, Quality Assurance Pharmacist, The Newcastle upon Tyne Hospitals NHS Foundation Trust WORKSHOP: CAPA Anne Black, Quality Assurance Pharmacist, The Newcastle upon Tyne Hospitals NHSFT & Adam Hocking, Principal Pharmacist Quality Assurance, University Hospital Southampton (coffee/tea to be taken during workshop) Workshop feedback session Preparing for EL(97)52 Audits and MHRA inspections – vital tips and guidance for service leads at all levels. Steve Parrish, Associate Director of Pharmacy, QE Hospital Birmingham End of day two and course, issue of certificates Please note that, although the organisers remain dedicated 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