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.:

Please quote purchase order number:

I wish to pay by credit card (Pharmig will contact you for details)

1st Delegate

First Name: Surname: Job Title:

2nd Delegate

First Name: Surname: Job Title:

Address : Tel:

Fax:

Email:

Discussion Session Attending gala dinner Special dietary requirements A B C D (included in fee)

1st Delegate:

2nd Delegate:

Please tick 2 sessions you wish to attend.

Pharmig

T5 The Maltings

Roydon Road

Stanstead Abbotts

Hertfordshire

SG12 8HG

United Kingdom.

Tel: +44 (0) 1920 871 999 Fax: +44 (0) 1920 871 156

Email: info@pharmig.org.uk Web: www.pharmig.org.uk