Pharmigs Annual Irish Conference - Hot Topics in Pharmaceutical Microbiology
Venue: Fota Island
19th May 2015
08.30 – 09.00 Registration
09.00 – 09.10
Chairs Welcome & Introduction
David Keen – Microbiology Manager, GlaxoSmithKline
09.10 - 09.45
Key Note Session: HPRA (formerly IMB) – Risk and Microbiology Session
Speaker: TBC– HPRA (Confirmed)
09.45 – 10.25
The Human Microbiome and its Implication for Cleanroom Microbiology
 The human microbiome and current research
 The microbiology of human skin
 Implications for cleanroom control
 Implications for personnel and cleanroom practices
 Implications for disinfectants and culture media
Dr Tim Sandle – Site Microbiologist, BPL
Pharmig’s Outstanding Contribution to Microbiology Award Winner 2013
10.25 – 11.10
Meet & Greet the Exhibitors with Tea/Coffee
11.10 – 11.50
Approach to Auditing Environmental Controls
 Introduction to environmental controls
 Audit planning and preparation activities
 Audit approach and high risk issue considerations
o Environmental control procedures
o Manufacturing facilities
o Cleaning
o Surface and air monitoring
o Water and gas systems
o Personnel controls
o Contract services
Elaine Doyle – Senior Compliance Auditor, Abbott
11.50 – 12.30
Biofilm Remediation Strategies
Biofilm remains a substantial challenge in maintaining clean processes within GMP regulated
industries. It is often difficult to determine the best approach to address the situation given the
myriad of key factors that can influence what products to test and conditions to evaluate. A
standardized biofilm reactor methodology combined with traditional cleaning was used to screen
numerous factors, such as water temperature, soil condition, commodity chemicals and rouged
stainless steel surfaces. Based on this research and experience with addressing microbial
contamination of process equipment, a holistic approach to remediate biofilm contamination will
be presented. The presentation will help you:

Understand the impact of biofilm to cleaning and disinfection
 Review standard biofilm test methods
 Provide a holistic approach to remediate biofilm contamination of process systems
Paul Lopolito – Technical Services Manager, Steris
12.30 – 13.30
Buffet lunch in exhibition area
13.30 – 14.15
Open discussion sessions
14.15 – 15.00
Open discussion session continued…
15.00 – 15.30
Tea/Coffee in the exhibition area
15.30 – 16.10
Bacterial Endotoxin Testing in the Pharmaceutical Industry
 What is a bacterial endotoxin and why do we test for them?
 Overview of bacterial endotoxin test methods
 Method validation of products
 Alternative Test Methods to LAL
 Low Endotoxin Recovery
Sarah Gray - Microbiological Technologist, GlaxoSmithKline
16.10 – 16.50
Data Integrity across the Instrument Lifecycle
 Project
o Data mapping
o Testing and risks
 Operation
o Change/incident management
o Periodic review
 Retirement
o Migration
o Archival
Matthew Curran – QA Representative (E-Systems) Lilly (TBC)
16.50 – 17.00
Chairs closing remarks
Open Discussion Sessions
Please choose 2 out of the 4 listed and mark accordingly on your booking form.
Session 1
Microbiological regulatory issues – Non - Steriles
Led by: Edel Fitzmaurice – Managing Director, Fitzmaurice Scientific Ltd
Session 2
Microbiological regulatory issues – Steriles
Led by: Jane Wyatt – Fine Focus (TBC)
Session 3
Rapid Methods and Microbial ID
Led by: Deirdre McCormack Lancaster Laboratories (TBC)
Session 4
Biofilms
Led by: Steris
HOTEL INFORMATION
The Venue
Fota Island Hotel and Spa is just 20 minutes from the airport and 15 minutes from the city centre. The hotel
has full conference facilities with accommodation, dining choices and leisure facilities which includes a full Spa
area. A limited number of bedrooms have been reserved at a special rate of €120 for overnight delegates
(please book early to avoid disappointment).
Fota Island also has full spa facilities which include a full fitness suite, swimming pool, hydrotherapy suite and
eighteen treatment rooms.
Address:
Fota Island Hotel and Spa, Fota Island, Cork, Ireland
Accommodation
This needs to be booked directly with the hotel.
Call The Fota Island Hotel and Spa on + 353 21 488 3700 - please quote Pharmig to ensure you receive the
discounted rate).
CANCELLATION POLICY:
Written cancellation will be accepted up to 30 days prior to the event, and all cancellations will incur a fee. No
refunds are available 15 working days before the start date and full course fees will be due for delegates who
fail to attend.Substitutions may be made at any time, preferably in writing to Maxine Moorey. Please send to:
Maxine Moorey, Pharmig, T5 The Maltings, Roydon Road, Stanstead Abbotts, Hertfordshire, SG12 8HG