pharmig 19th annual conference november 2011

Pharmigs 19th Annual ConferenceLatest updates and hot topics in Microbiology

atThe Nottingham Belfry Hotel

Mellor’s Way Off Woodhouse WayNottingham NG8 6PY

Wednesday 16th & Thursday 17th November 2011

About The Conference

At least 42 technical, social and business reasons why youshould attend:

2 Packed days of research-led topics that you, our Memberssaid were key to your everyday working practices9 Leading experts will share their knowledge and expertise –view the detailed programme to see who we have lined up foryou this year4 Open discussion sessions will allow you to extend yournetworking experience in a more informal environment1 AGM – all Members are encouraged to attend. Pharmigbelongs to you – and as such your views and opinions on how itshould move forward in the future to continue to meet yourneeds, are invaluable 1 Gala dinner and dance – relax and enjoy!24 Exhibitors who will demonstrate future industry trends and technologies and innovative solutions to current pressingindustry issues1 Prize draw – find out more when you attend!

Exhibition AreaOnce again we have secured a large exhibition area at the hotel. Asever, the commercial sector continues to form an integral part of thePharmig Conference and we so appreciate their support. We will beholding a ‘meet and greet’ during the breaks on Wednesday 16th

where each exhibitor will conduct a 2 minute presentation to a groupof delegates. The group will then rotate around the exhibition roomuntil all stands have been seen by the end of the last break.

The VenueThe Conference will be held at the Nottingham Belfry Hotel. Thisfour star hotel is located close to jct 26 of the M1. It has excellentconference facilities and also has a Reflections Spa and LeisureClub. A number of bedrooms have been reserved at a special ratefor overnight delegates (please book early to avoid disappointment -+44 (0) 115 973 9393).

Conference FeesConference fees are detailed below and include lunches,Conference banquet, refreshments and Conference documentation.Conference fees do not include accommodation and if Bed &Breakfast is required for either the 15th / 16th November youshould book directly with the hotel at the special rate of £109(call The Nottingham Belfry Hotel on +44 (0) 115 973 9393 -please quote Pharmig).

Cheques should be made payable to Pharmig and crossed A/CPayee only. Pharmig now accepts credit card payments too.Course fees are in Sterling/Euro and are VAT exempt. NB: Fees must be paid by 30th October 2011 in order toguarantee a place(s) at the Conference.

Pharmig’s 19th Annual Conference

Member Fees Non Member FeesDelegate £675 / €796* Delegate £975 / €1139*Bed & Breakfast £109 Bed & Breakfast £109(*Euro fee is higher to cover conversion rates)

NB: Discounted rates are available for non-profit making organisations.

NB: Please call the Pharmig office to discuss annual membershipfees to then be eligible for Member delegate rates.

Registration ProcessSimply complete the attached reply card and return directly toPharmig with your payment, or fax ahead your registration detailsto +44 (0)1920 871 156. Places are limited and reserved on a ‘First come, first served’ basis so book early to avoiddisappointment. All places will be held provisionally until fullpayment is received. Confirmation of an allocated space will besent by post with travel directions.

Please note: Fees must be paid before the date of theConference.

Cancellation PolicyWritten cancellation will be accepted up to 30 days prior to theevent, and all cancellations will incur a fee. No refunds are available15 working days before the start date and full course fees will bedue for delegates who fail to attend. Substitutions may be made atany time, preferably in writing to Maxine Moorey.

Pharmig Latest Publication & Training CD’s

A Guide to Microbiology Laboratories in the PharmaceuticalIndustrywill be launched at the November Conference• A one-stop shop for guidance on micro lab• Written from a global auditor, lab managers, industry experts

view points

Purchase now and receive a 10% discount on the publishedprices below

Member rate £60.00 Non Member rate £85.00To order – please tick the relevant box on the registration form

Plus to be launched before the Conference…

Pharmig will be producing their first two training CD’s on: Setting up and managing a training programme in the micro Lab& Best practices in microbiological control & documentation

• Feedback from those that attended the one-day meetingsincluded: ‘Very good overview’, ‘detail provided on essentialvalidation documents’, ‘excellent subject’, ‘covered many differentaspects of documentation’, ‘great overview of industryexpectations’, ‘very good course and very informative’.

• Member rate £75.00 Non member rate £99.00



Pharmigs 19th Annual Conference – Latest updates & hot topics in MicrobiologyNottingham Belfry Hotel, Nottingham - 16th & 17th November 2011

continued...

Wednesday 16th November 2011

09.00 – 09.15 Chairmans’ welcome and introductionTony Mayhall – Pharmig

09.15 – 09.30 Review of Pharmigs activities

09.30 – 10.10 KEY NOTE SESSIONRecent issues & observations during EU GMP Inspections

Issues with reference to microbiology labsand outcomes/resultsCommon GMP failing pointsOverlooked regulations

Neil Raw – GMP Inspector, MHRA

10.10 – 10.40 Sustaining a lean QC Microbiology laboratory –case study

Challenges encountered moving fromimplementation to sustainabilityTools for sustaining lean product testing andenvironmental monitoringKey performance indicators for the QCmicrobiology laboratory

Amy McDaniel – Director, QC Microbiology, Pfizer (USA)

10.40 – 10.55 Q&A

10.55 – 11.45 Meet & Greet the Exhibitors & Tea/Coffee

11.45 – 12.25 Risk based approach for determiningobjectionable micro organisms

Guidelines and regulations for objectionableorganismsWho should be involved in determiningwhether an organism is objectionableHow to determine whether a microorganismis objectionable through scientific risk-based assessments

Dr. Stephen Rawlings – Principal Microbiologist, GlaxoSmithKline

12.25 – 13.15 Open discussion sessions

13.15 – 14.15 Meet the exhibitors over a finger buffet lunch

14.15 – 14.55 Regulatory update - items of interest for the microbiologist A rapid walkthrough regulatory and compendial developments over the past twelve months, including:

Developments with the United States PharmacopeiaNew monographs for the EuropeanPharmacopeiaLatest ICH documentsISO standards in preparationNew FDA guidelinesThe important WHO document: pharmaceutical microbiology laboratoriesAnd other related documents.

Dr Tim Sandle – Company Microbiologist, BPL

14.55 – 15.35 Advances in Microbial IdentificationTraditional approaches to identification andwhy they are now changingStep by step guide to various



continued... diagnostic methods available:• PCR techniques• MALDI-TOF mass spectrometry - the theory

behind it & how it fits into the clinical scenarioExamples from 18 months use of MALDI-TOFmass spectrometry within the NHS environment.

Sarah Wallis – Registered Specialist Biomedical Scientist, Microbiology Dept Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

15.35 – 15.45 Q&A

15.45 – 16.15 Meet the exhibitors & Tea/Coffee

16.15 – 16.55 Risk management of contamination during cleanroom operations

Fundamental mechanism of contaminationtransferSources of contamination (particularly humans)Routes of transfer and risk diagramsGeneral cleanroom risk assessments andquantification of riskManagement of risk

Tim Eaton – Sterile Manufacturing Specialist, AstraZeneca

16.55 – 17.05 Q&A

17.05 – 17.15 Summary and close of day one

17.30 – 18.00 AGM (All Members please do attend)

19.00 – 20.00 Pre-dinner drinks

20.00 ‘till late Conference dinner and dance (smart/casual attire)

Thursday 17th November 2011

09.00 – 09.05 Chairman’s opening remarks

09.05 – 09.45 Sterility Failure – What happens next?Re-tracing steps – what went wrong?Suitable investigation proceduresDeveloping an appropriate SOP

Neil Raw – GMP Inspector, MHRA

09.45 – 10.25 The manufacturing plant microbiologist – breaking barriers and building relationships

Earning the respect of operation teams andbuilding confidenceUnlocking data and sharing processunderstandingAssuring competence

Scott Smith – Microbiology QC Leader, Sanofi-Aventis

10.25 – 10.40 Q&A

10.40 – 11.30 Open discussion sessions cont…

11.30 – 12.00 Meet the exhibitors & Tea/Coffee

12.00 – 12.20 Committee reporter feedback/summary from discussion sessions

12.20 – 13.00 Best practices for performing contamination investigations

Assessing contamination accuracyKey factors for carrying out an effective and continued...


quick investigation: development of a check listPlanning an effective corrective/preventativeaction plan (CAPA)Follow up: When is an investigation reallycompleted?

David Keen – Supply Microbiology Manager, Reckitt Benckiser

13.00 – 14.00 Meet the Exhibitors over finger buffet lunch

14.00 – 14.40 How to justify doing less monitoring, sampling and testing and still pass an inspection

What do the regulators currently say aboutmonitoring and testing with particular referenceto EM and process water samplingUtilising "parametric release" conceptsHow you can apply risk based approaches tomonitoring and testingPutting together the data package to supportyour approach

Stewart Green – Managing Director, GXP Consulting

14.40 – 15.20 Developing a meaningful environmental monitoring programme for sterile/non sterile products

Methods of monitoring, specifications and alertlevelsSelection of location and risk analysisData management, trending and review ofenvironmental monitoring programme

Dr Julia Mottishaw – QP, Teva Runcorn

15.20 – 15.30 Q&A

15.30 – 15.40 Summary and close of Conference

15.40 – 16.00 Departure Tea/Coffee

Open Discussion Sessions

Session 1: Applications of risk assessment in the microbiologylaboratory Amy McDaniel, Pfizer

Session 2: Cleaning & Disinfectant Validation Kim Morwood, MGS

Session 3: What is an objectionable organism? Stephen Rawling,GlaxoSmithKline

Session 4: Method Validation Julia Mottishaw, Teva Runcorn

Please state which two open discussion sessions you would like toattend on your reply card

Sponsorship and Exhibition Opportunities:We have a selection of promotional packages available from sponsoringthe gala dinner through to exhibition stands and inserts in theconference folders, with competitive prices to suit all budgets.

Interested? Then please contact:

Maxine Moorey on:

Tel: +44 (0) 1920 871999Email: [email protected]


continued...

Please note Pharmig reserves the right to alter the programme in the event of unforeseen circumstances. Please note that the views expressed by individual contributors are their ownand do not necessarily reflect the views of Pharmig as a whole.

1 2 3 4


Cheques should be made payable to “Pharmig” and attached to this form for a confirmedplace or fax this booking form to +44 (0) 1920 871 156 for a provisional place.

I wish to purchase ________ copy(ies) of the Guide to Microbiology Laboratories in thePharmaceutical Industry at the 10% discounted rate on the published price

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 card details)

Please state any specific dietary requirements:

Attendee 2

Surname:

First name:

Job Title:

Registration Form

Please reserve place(s) for Pharmig’s 19th Annual Conference held at The Nottingham Belfry Hotel on the 16th & 17th November 2011.

Company: ............................................................................................................

Address:

Address: ................................................................................................Address:

A

Adress:…………………………………………………………

Tel:……………………………………………………………………


Attendee 1

Surname:

First name:

Job Title:

1 2 3 4


NB: Fees must be paid by October 30th 2011 inorder to guarantee a place(s) at the Conference.

Member Fees Non Member Fees

Delegate £675 / €796* Delegate £975 / €1139*

Bed & Breakfast £109 Bed & Breakfast £109

(*Euro fee is higher to cover conversion rates)

Cancellation PolicyWritten cancellation will be accepted up to 30 days prior to the event, and allcancellations will incur a fee. No refunds are available 15 working days beforethe 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.

Tel: +44 (0)1920 871999 Fax: +44 (0)1920 871156 Email: [email protected] www.pharmig.org.uk

Maxine MooreyExecutive DirectorPharmigT5 The MaltingsRoydon RoadStanstead AbbottsHertfordshireSG12 8HGUnited Kingdom

pharmig 19th annual conference november 2011

Documents