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Attend and hear about:• Deviation Management: Identification of Isolates
• Designing a Bioburden Control Strategy
• Effective Investigations
• Approaches to Auditing Environmental Controls
• Is your Phone, Handbag and Computer Bugged?...
• And more…!
Latest updates and hot topics in Microbiology
Elaine Doyle Abbott
Alan Whipple GlaxoSmithKline
Mary-Anne Weatherhead Pfizer
Chris Wells bioMériuex UK Ltd
Dr. Tim Sandle Bio Products Laboratory
Dr. Samantha Westgate Perfectus Biomed Ltd
Prof. Val Edwards-Jones MelBec Microbiology UK Ltd
Dr. Mark Sutton Public Health England
Joanne Spiers Catalent Pharma Solutions
Patrick Nieuwenhuizen Genzyme
Kevin Wright Proctor & Gamble
Leading microbiology experts include:
Early Bird OfferSending 2 people?
Book before the 8th October and the second
delegate receives a 50% discount on
listed prices
22nd Annual Event
PLUS Special
discounts for NHS See booking page
for further details
Venue: Nottingham Belfry, Mellors Way, Off Woodhouse Way, Nottingham, NG8 6PY
Date: 26th & 27st November 2014
08.30 – 09.00 Registration
09.00 – 09.15 Chairman’s welcome and introduction David Keen – Microbiology Manager,
GlaxoSmithKline and Pharmig Chair
09.15 – 10.00 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 10.00 – 10.45 Use of Plant Isolates in QC Testing and
Pharmaceutical Microbiology Validation • Guidelines and regulations • Pros and cons of plant isolate usage • Plant isolates versus pharmacopoeial
Reference strains • What to choose and when to change • Benefits of using plant isolates Chris Wells – Director Global Key Account Management, bioMériuex UK Ltd
10.45 – 11.30 Meet the exhibitors over tea & coffee
11.30 – 12.15 Cleanroom Behaviour, Aseptic Practices and Operator Understanding
• Evaluating operator cleanroom behaviour • Developing a feedback and learning
culture around cleanroom behaviour • Avoiding common regulatory observations
on aseptic technique • Relating operator performance to
environmental monitoring excursions Patrick Nieuwenhuizen – Manager Quality
Control, Genzyme
12.15 – 13.00 Open discussion sessions
13.00 – 13.30 Pharmig AGM All Members please do attend to receive an
update on Pharmig activities and voice your thoughts!
13.30 – 14.30 Finger buffet lunch in the exhibition area
14.30 – 15.15 Approach to Auditing Environmental Controls
• Introduction to environmental controls • Audit planning and preparation activities • Audit approach and high risk issue
considerations • Environmental control procedures • Manufacturing facilities • Cleaning • Surface and air monitoring • Water and gas systems • Personnel controls • Contract services
Elaine Doyle – Senior Compliance Auditor, Abbott
15.15 – 16.00 Deviation Management: Identification of Isolates
• When should you identify? • Every colony isolated? • Only in case of an excursion of limits /
level? • How far to identify – presumptive vs
species level • How should we use the ID information? Alan Whipple – Microbiology Director, GlaxoSmithKline
16.00 – 16.30 Tea & coffee with the exhibitors
16.30 – 17.15 QPs and Microbiologists – How to Build Partnerships
• What useful information can the microbiologist supply to the QP?
• How to make a QP interested in your data • What data to leave out • Why should microbiologists become QPs? Mary-Anne Weatherhead – Qualified
Person, Pfizer
17.15 – 17.30 Summary & close of day one
19.00 – 20.00 Pre-dinner drinks in the exhibition area
20.00 ‘till late Gala dinner and dance (smart/casual dress code)
Latest updates and hot topics in MicrobiologyWednesday 26th November 2014
22nd Annual Event Latest updates and hot topics in Microbiology2
Latest updates and hot topics in MicrobiologyWednesday 26th November 2014
22nd Annual Event Latest updates and hot topics in Microbiology
09.00 – 09.05 Chair’s opening remarks and champagne draw
09.05 – 09.15 Pharmig Publications Update Dr. Tim Sandle – Site Microbiologist, BPL & Pharmig Committee Member
09.15 – 10.00 Prevention is Better than a Cure: Designing a Bioburden Control Strategy
Your production has restarted, the affected batches of raw material and product quarantined for disposal, and the message from management can be summarised as – `this has never happened before, and we don’t want it to happen again.̀ The words `opportunity, compliance, review and yesterday` come into your life as you revisit the monitoring of potential sources, and the changes which resulted in microbial contamination. Your sole purpose is to make sure you fully understand the impact of the inherent bioburden in your FMCG manufacturing system, leveraging a combination of quality data and potential new measures to pragmatically manage the risks for the future.
This talk will provide an overview of where you might want to look in managing bioburden within production cycle, touching on sampling approaches, methods, supply chain, limits, risk in context, and the value of integrated knowledge across your products and the manufacturing process.
Kevin Wright – Principle Scientist, Procter & Gamble
10.00 – 10.45 Effective Investigations • Understanding the problem • Identifying the correct root cause • Corrective and preventative actions • Discussion of practical examples Joanne Spiers – VP, Quality Operations
& Regulatory Compliance, Catalent Pharma Solutions
10.45 – 11.15 Tea & coffee with exhibitors
11.15 – 12.00 Open discussion session continued
12.00 – 12.20 Committee reporter feedback / summary from discussion sessions
12.20 – 13.00 Industrial Biofilms, the Problems Encountered and Possible Management Methods
• Biofilm definition and explanation of how it forms
• Biofilm attachment and attachment surfaces
• How do industrial biofilms differ from lab based biofilms?
• Possible consequences of biofilm contamination
• Management methods to prevent/control biofilm formation
Dr. Samantha Westgate – Director, Perfectus Biomed Ltd 13.00 – 14.00 Finger buffet lunch
14.00 – 14.45 Monitoring of Hydrogen Peroxide Decontamination Processes; Is There a Better Way?
• The challenges of using biological indicators (BIs) to monitor gaseous decontamination processes • Shortcomings of existing Geobacillus
stearothermophilus BIs • Microbial organisms and lifestyles
that are a greater challenge to decontamination
• Development of thermostable adenylate kinase (tAK) indicators as a rapid read-out surrogate marker for assessing decontamination process efficacy
• Comparison of tAK indicator and BI performance in laboratory studies of two commercial hydrogen peroxide decontamination systems
• Building a case to support implementation of tAK indicators in pharma
Dr. Mark Sutton – Scientific Leader, Healthcare Biotechnology, Public Health England
Latest updates and hot topics in MicrobiologyThursday 27th November 2014
3
PROGRAMME CONTINUES OVERLEAF
A) Low Endotoxin RecoveryLow Endotoxin Recovery (LER) has recently become a hot topic for discussion amongst Bacterial Endotoxin Test (BET) users. Is this a new phenomenon or has it been observed for some time? The aim is to discuss the current literature and industry position with thoughts on the validation of the BET with the more complex and challenging molecules of today and taking Pharmig members own validation experiences with this issue.Led by: Mark Childs – UK General Manager, Associates of Cape Cod & Edel Fitzmaurice, Fitzmaurice Scientific Ltd
B) Pharmig Expert Corner - Q&A with Pharmig Committee Members (sterile and non-sterile) Led by: Andy Brack, PZ Cussons & Andy Martin, ABM Consulting - Pharmig Committee
C) Best Practices in Cleanrooms- Identifying issues relating to cleanrooms- Launching Pharmigs Cleanroom Action GroupLed by: Brian Hayes, Ipsen & Tim Sandle, BPL
D) Use of Plant Isolates Led by: Alan Whipple, GlaxoSmithKline & Julie Roberts, J. Roberts Associates Ltd
The aim of these sessions is to encourage discussion, share issues, solutions and experiences in a smaller, more informal environment helping you to benchmark against other delegates/companies.
Open Discussion SessionsWednesday 26th November & Thursday 27th November
22nd Annual Event Latest updates and hot topics in Microbiology4
14.45 – 15.30 Is your Phone, Handbag and Computer Bugged? The Microbiology of Everyday Objects and Risk of Infection
There is huge concern in the microbiology community about the increasing numbers of multi-antibiotic resistant bacteria in the health care environment. We know that infections associated with these organisms have a higher fatality for those persons undergoing complicated medical treatment. Should we be worried?
There is evidence that these organisms have now spread into the general community and we have isolated some common everyday objects, including the dog! Should we be worried?
This lecture will explore the relevance of these problems to the general public and how prevention of some common infectious diseases can be achieved by following good hygienic practices.
Professor Val Edwards-Jones – Clinical Director, MelBec Microbiology Ltd, UK
15.30 – 15.40 Summary and Close of Conference
15.40 – 16.00 Departure Tea & Coffee
Latest updates and hot topics in MicrobiologyThursday 27th November 2014 (Continued)
22nd Annual Event Latest updates and hot topics in Microbiology 5
Latest updates and hot topics in MicrobiologyThursday 27th November 2014 (Continued)
Pharmig would like to thank the following companies who are exhibiting at this years’ conference and for their continuing support.
22nd Annual Event Latest updates and hot topics in Microbiology6
Launching Pharmig’s latest Fact Sheet Range A series of 8 fact sheets about the major Objectionable Microorganisms
One of the expectations of GMP regulators is that microbiology laboratories are knowledgeable about the main objectionable microorganisms that could be found in pharmaceutical products or in the manufacturing environment. The identification, characterisation and interpretation of these microorganisms can be challenging. To act as a training aid and information resource, Pharmig have produced eight new fact sheets (Fact Sheet Pack 2). Seven of the fact sheets profile some of the most important objectionable microorganisms (together with Geobacillus stearothermophilus, used for biological indicators). An eighth fact sheet provides useful information about risk assessing objectionable microbes.
The fact sheets use colour photographs illustrating growth on agar and by Gram-stain. These are supported by facts relating to the organism’s profile and methods for identification.
The sheets are presented in a pack and together provide a unique, informative and colourful guide to an important area of quality control microbiology.
Also available are a set of fact sheets outlining the specified microorganisms relating to the pharmacopeial Microbial Limits Test (Fact Sheet Pack 1).
Member price £30Non Member price £50
Pharmig’s range of publications also include the following (more details of which can be found on the website www.pharmig.org.uk/publications and on the Pharmig stand at the Conference)
Organism descriptionStenotrophomonas maltophilia is a Gram-negative bacterium found in a variety of environments including soil, water, and plants. It also occurs in the hospital environment and may cause infections such as, bloodstream infections, respiratory infections, urinary infections and surgical-site infections. It was previously known as Pseudomonas maltophilia and Xanthamonas maltophilia
Objectionable statusS. maltophilia is one of the most commonly isolated bacteria from pharmaceutical water systems. In hospitals, S. maltophilia has been associated with antibiotic resistance. S. maltophilia frequently colonizes breathing tubes such as endotracheal or tracheostomy tubes, the respiratory tract and urinary catheters.
HabitatS. maltophilia is ubiquitous in aqueous environments, soil and plants. In addition, S. maltophilia can exist in nearly any liquid-fi lled cavity in the human body, including the circulatory system.
Other featuresS. maltophilia are slightly smaller (0.7–1.8
Objectionable Microorganisms Stenotrophomonas maltophilia
FACTSHEET
14
× 0.4–0.7 µm) than other members of the genus. Coloionies may be yelloe ot greenish yellow. They are motile due to polar fl agella and grow well on MacConkey agar producing pigmented colonies. S. maltophilia are catalase-positive, oxidase-negative (which distinguishes them from most other members of the genus) and have a positive reaction for extracellular DNase.
S. maltophilia also is studied for the use of bio-pesticides.
Identifi cationS. maltophilia is a Gram-negative aerobic rod-shape bacterium and motile with a few polar fl agella. It can be identifi ed
Objectionable Microorganisms | Stenotrophomonas maltophilia
Version 01 • Page 1 of 2 • November 2014Pharmig, T5 The Maltings, Roydon Road, Stanstead Abbotts, Hertfordshire, SG12 8HG
Microbial Limits Test (Fact Sheet Pack 1).
LAL Factsheets(pack of 6)
22nd Annual Event Latest updates and hot topics in Microbiology 7
PHARMIG 22ND ANNUAL CONFERENCE26TH & 27TH NOVEMBER 2014
CANCELLATION POLICYWritten 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.
Maxine Moorey PharmigT5 The MaltingsRoydon RoadStanstead AbbottsHertfordshire, SG12 8HG
ACCOMMODATION To book your accommodation at the Nottingham Belfry Hotel at the rate of £105 pp B&B please contact the hotel directly on: Tel: 0115 973 9393 Please state you are booking for the Pharmig Conference November 2014 to ensure you receive the discounted rateNOTE: Rooms get booked up very quickly – early booking is recommended
HOTEL INFORMATION Nottingham Belfry Hotel, Mellors Way, Off Woodhouse Way,Nottingham, NG8 6PY The Nottingham Belfry Hotel is a four star hotel is located close to jct 26 of the M1. It has excellent conference facilities and also has a Reflections Spa and Leisure Club.
Tel: +44 (0) 1920 871 999 Fax: +44 (0) 1920 871 156 Email: info@pharmig.org.uk
CONFERENCE FEESConference fees are detailed below and include lunches, Conference gala dinner & dance, refreshments and Conference documentation. Conference fees do not include accommodation, which must be booked and paid for directly with the hotel. NB: Fees must be paid by October 26th 2014 in order to guarantee a place(s) at the Conference.
PHARMIG MEMBER FEES NON MEMBER FEES Delegate £695 / @ 890 Delegate £995 / @ 1266Bed & Breakfast £105 Bed & Breakfast £105
Discounted rates are available for NHS and non-profit making organisations NHS Member Fees £350 Non NHS Member Fees £450
BOOKING FORM BOOK BY THE 8th OCTOBER & A SECOND DELEGATE CAN ATTEND AT A 50% DISCOUNT (both bookings must be made at the same time)
* Euro fee is higher to cover conversion rates
Cheques should be made payable to ‘Pharmig’ and attached to this form for a confirmed place or fax / email this booking form to +44 (0) 1920 871 156 / info@pharmig.org.uk for a provisional place.
Cheque for £ sterling / @ euro to cover delegate fee(s) enclosed
Cheque for £ sterling / @ euro to follow
Total of £ sterling / @ euro transferred electronically
Please supply invoice F.A.O.:
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1st Delegate
First Name: Surname: Job Title:
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Discussion Session Attending gala dinner Special dietary requirements A B C D (included in fee)
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Please tick 2 sessions you wish to attend.
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