Pharmigs 19th Annual Conference Latest updates and hot topics in Microbiology

Wednesday 16th & Thursday 17th November 2011

at The Nottingham Belfry Hotel Mellors Way Off Woodhouse Way Nottingham NG8 6PY

About The Conference

At least 42 technical, social and business reasons why you should attend: 2 Packed days of research-led topics that you, our Members said were key to your everyday working practices 9 Leading experts will share their knowledge and expertise view the detailed programme to see who we have lined up for you this year 4 Open discussion sessions will allow you to extend your networking experience in a more informal environment 1 AGM all Members are encouraged to attend. Pharmig belongs to you and as such your views and opinions on how it should move forward in the future to continue to meet your needs, 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 pressing industry issues 1 Prize draw find out more when you attend!

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

The Venue
The Conference will be held at the Nottingham Belfry Hotel. This 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. A number of bedrooms have been reserved at a special rate for overnight delegates (please book early to avoid disappointment +44 (0) 115 973 9393).

Conference Fees
Conference 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 you should 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/C Payee 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 to guarantee a place(s) at the Conference.

Exhibition Area
Once again we have secured a large exhibition area at the hotel. As ever, the commercial sector continues to form an integral part of the Pharmig Conference and we so appreciate their support. We will be holding a meet and greet during the breaks on Wednesday 16th

Pharmigs 19th Annual 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) NB: Discounted rates are available for non-profit making organisations. NB: Please call the Pharmig office to discuss annual membership fees to then be eligible for Member delegate rates.

Pharmig Latest Publication & Training CDs

A Guide to Microbiology Laboratories in the Pharmaceutical Industry will 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 published prices below Member rate 60.00 Non Member rate 85.00 To 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 CDs 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 meetings included: Very good overview, detail provided on essential validation documents, excellent subject, covered many different aspects of documentation, great overview of industry expectations, very good course and very informative. Member rate 75.00 Non member rate 99.00

Registration Process
Simply complete the attached reply card and return directly to Pharmig with your payment, or fax ahead your registration details to +44 (0)1920 871 156. Places are limited and reserved on a First come, first served basis so book early to avoid disappointment. All places will be held provisionally until full payment is received. Confirmation of an allocated space will be sent by post with travel directions. Please note: Fees must be paid before the date of the Conference.

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.

Pharmigs 19th Annual Conference

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

Wednesday 16th November 2011

09.00 09.15 Chairmans welcome and introduction Tony Mayhall Pharmig Review of Pharmigs activities

09.15 09.30

09.30 10.10

KEY NOTE SESSION Recent issues & observations during EU GMP Inspections Issues with reference to microbiology labs and outcomes/results Common GMP failing points Overlooked regulations Neil Raw GMP Inspector, MHRA Sustaining a lean QC Microbiology laboratory case study Challenges encountered moving from implementation to sustainability Tools for sustaining lean product testing and environmental monitoring Key performance indicators for the QC microbiology laboratory Amy McDaniel Director, QC Microbiology, Pfizer (USA) Q&A Meet & Greet the Exhibitors & Tea/Coffee Risk based approach for determining objectionable micro organisms

Guidelines and regulations for objectionable organisms Who should be involved in determining whether an organism is objectionable How to determine whether a microorganism is objectionable through scientific risk-based assessments Dr. Stephen Rawlings Principal Microbiologist, GlaxoSmithKline 12.25 13.15 13.15 14.15 14.15 14.55 Open discussion sessions Meet the exhibitors over a finger buffet lunch 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 Pharmacopeia New monographs for the European Pharmacopeia Latest ICH documents ISO standards in preparation New FDA guidelines The important WHO document: pharmaceutical microbiology laboratories And other related documents. Dr Tim Sandle Company Microbiologist, BPL Advances in Microbial Identification Traditional approaches to identification and why they are now changing continued... Step by step guide to various

10.10 10.40

10.40 10.55 10.55 11.45 11.45 12.25

14.55 15.35

Pharmigs 19th Annual Conference

Pharmigs 19th Annual Conference Latest updates & hot topics in Microbiology
Nottingham Belfry Hotel, Nottingham - 16th & 17th November 2011
continued... diagnostic methods available: PCR techniques MALDI-TOF mass spectrometry - the theory behind it & how it fits into the clinical scenario Examples from 18 months use of MALDI-TOF mass spectrometry within the NHS environment. Sarah Wallis Registered Specialist Biomedical Scientist, Microbiology Dept Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust Q&A 09.45 10.25 15.45 16.15 16.15 16.55 Meet the exhibitors & Tea/Coffee Risk management of contamination during cleanroom operations Fundamental mechanism of contamination transfer Sources of contamination (particularly humans) Routes of transfer and risk diagrams General cleanroom risk assessments and quantification of risk Management of risk Tim Eaton Sterile Manufacturing Specialist, AstraZeneca Q&A Summary and close of day one 12.20 13.00 17.30 18.00 19.00 20.00 AGM (All Members please do attend) Pre-dinner drinks Best practices for performing contamination investigations Assessing contamination accuracy Key factors for carrying out an effective and continued... The manufacturing plant microbiologist breaking barriers and building relationships Earning the respect of operation teams and building confidence Unlocking data and sharing process understanding Assuring competence Scott Smith Microbiology QC Leader, Sanofi-Aventis Q&A Open discussion sessions cont Meet the exhibitors & Tea/Coffee Committee reporter feedback/summary from discussion sessions 20.00 till late Conference dinner and dance (smart/casual attire)

Thursday 17th November 2011

09.00 09.05 09.05 09.45 Chairmans opening remarks Sterility Failure What happens next? Re-tracing steps what went wrong? Suitable investigation procedures Developing an appropriate SOP Neil Raw GMP Inspector, MHRA

15.35 15.45

10.25 10.40 10.40 11.30 11.30 12.00 12.00 12.20

16.55 17.05 17.05 17.15

Pharmigs 19th Annual Conference

Pharmigs 19th Annual Conference Latest updates & hot topics in Microbiology
Nottingham Belfry Hotel, Nottingham - 16th & 17th November 2011
continued... quick investigation: development of a check list Planning an effective corrective/preventative action plan (CAPA) Follow up: When is an investigation really completed? David Keen Supply Microbiology Manager, Reckitt Benckiser Meet the Exhibitors over finger buffet lunch Session 2: Cleaning & Disinfectant Validation Kim Morwood, MGS 14.00 14.40 How to justify doing less monitoring, sampling and testing and still pass an inspection What do the regulators currently say about monitoring and testing with particular reference to EM and process water sampling Utilising "parametric release" concepts How you can apply risk based approaches to monitoring and testing Putting together the data package to support your approach Stewart Green Managing Director, GXP Consulting Developing a meaningful environmental monitoring programme for sterile/non sterile products Methods of monitoring, specifications and alert levels Selection of location and risk analysis Data management, trending and review of environmental monitoring programme Dr Julia Mottishaw QP Teva Runcorn , Q&A
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 own and do not necessarily reflect the views of Pharmig as a whole.

15.30 15.40 15.40 16.00

Summary and close of Conference Departure Tea/Coffee

Open Discussion Sessions

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

13.00 14.00

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 to attend on your reply card

Sponsorship and Exhibition Opportunities:

We have a selection of promotional packages available from sponsoring the gala dinner through to exhibition stands and inserts in the conference folders, with competitive prices to suit all budgets. Interested? Then please contact: Maxine Moorey on: Tel: +44 (0) 1920 871999 Email: Maxine@pharmig.org.uk

14.40 15.20

15.20 15.30

Pharmigs 19th Annual Conference

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

Company: Address: Address: A

............................................................................................................ Attendee 1 Surname: ................................................................................................Address: First name: Job Title: Attendee 2

Open Discussion Sessions
1 2 3 4

Open Discussion Sessions

1 2 3 4

Adress:

Tel: Surname: First name: Job Title:

Cheques should be made payable to Pharmig and attached to this form for a confirmed place 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 the Pharmaceutical Industry at the 10% discounted rate on the published price Cheque for Cheque for Total of sterling / sterling / euro to cover delegate fee(s) enclosed euro to follow euro transferred electronically

NB: Fees must be paid by October 30th 2011 in order 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

sterling /

(*Euro fee is higher to cover conversion rates)

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 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:

Pharmigs 19th Annual Conference

Maxine Moorey Executive Director Pharmig T5 The Maltings Roydon Road Stanstead Abbotts Hertfordshire SG12 8HG United Kingdom

Tel: +44 (0)1920 871999

Fax: +44 (0)1920 871156

Email: info@pharmig.org.uk

www.pharmig.org.uk