Current Hot Topics in Pharmaceutical Microbiology 18th May 2016

Venue: Fota Island Hotel, Cork

Dr Tim Sandle, BPL

Bharat Patel, Public Health England

David Keen, GlaxoSmithKline

Gordon Farquharson, Critical Systems

Julie Roberts, J Roberts Associates

Rachel Blount, Ecolab

Edel Fitzmaurice, Fitzmaurice Scientific Ltd

Lee Eyres, Cristal Cleat Engineering

Richard Sinden, Suez

David Keen, GlaxoSmithKline

Leading experts include:

Discounts apply for each event and for

those wanting to attend both

OFFERS END 15TH APRIL 2016

(see booking form for further information)

Presents

Control of Pharmaceutical Water Systems 19th May 2016

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

08.30 - 09.00 Registration

09.00 - 09.10 Chairs Welcome & Introduction David Keen – Plant Microbiology

Manager, GlaxoSmithKline and Pharmig Chairman

09.05 - 09.45 Annex 1 Revision – A Review of the Scope and Rationale for Likely Changes.

Annex 1 of the EU GMP is under revision current by a joint team of inspectors from the EMA and PIC/S. The rapporteur is Andrew Hopkins of the UK MHRA. This presentation is a review of what we have learned recently from Mr Hopkins about the likely scope of revision and the timeline. An element of the revision concerns the addition of new material related to GMP aspects of the manufacture of WFI. The presentation will include a digest of recent explanations by Dr Susan Keitel, EDQM, Council of Europe of the revised Ph.Eur monograph for WFI, and the relationship with Annex 1.

• Sources of information • The motivation for changes • Will a joint EMA & PIC/S document

be different? • Revisions - Correction of errors - New WFI and bio-film guidance - Accommodating ISO 14644- 1&2:2015 - The impact of maturing technologies

such as isolators, closed systems and disposables

• Timeline Gordon Farquharson – Director & Principle Consultant, Critical Systems Ltd & Working in International Standardisation & Chair UK BSI LBI/030; Chair CEN TC243; Convenor ISO TC209 wg1

09.45 - 10.25 Data Integrity and New Expectations • What is data integrity? • Requirements for good data

integrity - ‘ALCOA’ • Understanding the expectations from

Regulators • Managing data integrity in your

laboratory and at your production facility

• Regulatory guidance on data integrity

Julie Roberts – Quality Director, J Roberts Associates Ltd & Pharmig Committee Member

10.25 - 11.10 Meet & Greet the Exhibitors with Tea/Coffee

11.10 - 11.50 Environmental Monitoring: Incubation Strategies • What is environmental monitoring

trying to do? • Which agar should you select? • Should one or two agars be used? • Which is the optimal temperature? • For how long should you incubate for? • What types of microorganisms can you

expect to detect? Tim Sandle – Head of Microbiology, BPL

11.50 - 12.30 Regulatory Requirements and Hot Topics in Relation to Contamination Control

• The regulatory requirements with regards to cleaning and disinfection

• Observed regulatory expectations with regards to cleaning and disinfection

• Recommendations for compliance from observed practice

• Examples of non-compliance (from FDA Warning Letters)

Rachel Blount - Global Validation Manager, Team Leader, ECOLAB

12.30 - 13.30 Buffet Lunch in Exhibition Area

13.30 - 14.10 Open Discussion Sessions

14.10 - 14.50 Open Discussion Session Continued…

14.50 - 15.20 Tea/Coffee in the Exhibition Area

15.20 - 16.00 Session TBC

16.00 - 16.40 Contamination Control: Effectively Managing the Change Control Processes

• How does your change control let your bugs run amok?

• How can a microbiologist influence engineering change?

• How is change control managed? • Who decides if a change is significant? David Keen – Plant Microbiology Manager,

GlaxoSmithKline and Pharmig Chairman

Hot Topics In Pharmaceutical MicrobiologyWednesday 18th May 2016

Hot Topics In Pharmaceutical Microbiology - Wednesday 18th May2

Programme continued overleaf…

Hot Topics In Pharmaceutical Microbiology - Wednesday 18th May 3

Open Discussion Sessions Tuesday 19th May 2015Please choose 2 out of the 3 listed and mark accordingly on your booking form.

Session 1 Annex 1 and ISO 14644 Updates Led by: Gordon Farquharson – Director & Principle Consultant, Critical Systems (TBC) & Dr. Tim Sandle – Site Microbiologist, BPL

Session 2 Data Integrity Led by: Julie Roberts – Quality Director, J R Roberts Associates

Session 3 Disinfectant Efficacy Testing Led by: Rachel Blount – Global Validation Manager, Ecolab

16.40 - 16.50 Chairs Closing Remarks

For those of you who are staying over for the Control of Pharmaceutical Water Systems meeting tomorrow – Pharmig will be hosting a small drinks reception this evening 7pm – 8pm. Delegates will need to make their own dinner arrangements at the hotel.

Hot Topics In Pharmaceutical MicrobiologyContinuedWednesday 18th May 2016

Control of Pharmaceutical Water Systems - Thursday 19th May 20164

Control of Pharmaceutical Water SystemsThursday 19th May 2016Fota Island, Cork

09.00 - 09.30 Registration with Tea/Coffee

09.30 - 09.45 Chairs Introduction David Keen – Plant Microbiology

Manager, GlaxoSmithKline and Pharmig Chairman

09.45 - 10.30 Setting the Scene - Pseudomonas and Water: A Practical Insight from PHE (Public Health England)

• Pseudomonas Northern Ireland - more than an outbreak:

Over the course of two months, 25 babies were affected by pseudomonas in Neonatal Intensive Care Units in Northern Ireland. There were 5 deaths, although one was not reported as pseudomonas. A wide ranging independent review increased our understanding of the link between pseudomonas and water; contributed to national guidance; and identified important lessons for Northern Ireland and beyond.

• What we know now! Bharat Patel – Consultant Medical

Microbiologist, PHE (Public Health England)

10.30 - 11.00 Current Hot Topics and Common Audit Citations in Water

Edel Fitzmaurice - Managing Director, Fitzmaurice Scientific Ltd

11.00 - 11.30 Morning Break with Tea/Coffee

11.30 - 12.15 Water Systems • Operation • Maintenance • Disinfection • Critical parameters • Design & qualification

Lee Eyres – Owner, Crystal Clear Engineering

12.15 - 13.00 Water Validation and Regulatory Compliance

• The microbiological and chemical quality requirements for water under EU regulations

• Microbiological testing methods • The impact of water borne microbes

• Control and prevention • Regulatory factors and timelines

Richard Sinden - Life Sciences Product Innovation and Regulation Director, Suez

13.00 - 14.00 Lunch

14.00 - 14.45 Biofilms in Water Systems: A Practical Perspective

• What the risk are to water quality • How do you control it? • How do you remove it? • Can you actually measure it?

Lee Eyres – Owner, Crystal Clear Engineering

14.45 - 15.30 Purified Water Systems • What can a purified water system

consist of? • Microbial risks of a purified water

system David Keen – Plant Microbiology Manager, GlaxoSmithKline and Pharmig Chairman

15.30 - 16.00 Afternoon break with Tea/Coffee

16.00 - 16.45 Case Study on Purified Water Systems You are running a manufacturing and oral dose facility and your purified water system falls over!

As a group you will work out how you would:

• Cope with bugs coming out of your purified water system

• Deal with a loss of your site water supply?

Previous case studies have been extremely well received by delegates – encouraging networking and exchange of thoughts and ideas whilst being guided by experienced leaders. An informative, thoughtful and fun way to end the meeting!

David Keen – Plant Microbiology Manager, GlaxoSmithKline and Pharmig Chairman

16.00 - 16.15 Summary & Chair’s Closing Remarks

Booking Form and Hotel Information 5

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)

Booking Form and Hotel Information

BOOKING FORM BControl of Pharmaceutical Water Systems – Thursday 19th May 2016

Member Fees Non Member Fees1st Member - e525 / £395 1st Non Member - e780/ £595 2nd Member - e395 / £295 2nd Non Member - e650 / £495 Send 2 or more people from the same company and receive a discount on the full price as outlined above

BOOKING FORM C – BOOKING BOTH the One-Day Conference & Control of Pharmaceutical Water Systems – 18th & 19th May 2016

If you wish to attend both meetings – further discounted fees are as follows:

Member Fees Non Member Fees1st Member - e975/ £745 1st Non Member - e1485 / £1145 2nd Member - e715 / £545 2nd Non Member - e1230 / £945

HURRY!DISCOUNTED

OFFERS END 15TH APRIL 2016

1st Delegate

First Name:

Surname:

Job Title:

Company Name:

Address:

Email:

Dietary Requirements:

2nd Delegate

First Name:

Surname:

Job Title:

Company Name:

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Please circle the relevant meeting fee (s) outlined in Booking Form A, B or C below

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.

BOOKING FORM AHot topics in Pharmaceutical Microbiology – Tuesday 19th May 2015

Member Fees Non Member Fees1st Member - e650 / £495 1st Non Member - e910 / £6952nd Member - e525 / £395 2nd Non Member - e780/ £595Send 2 or more people from the same company and receive a discount on the full price as outlined above

DISCUSSION SESSIONS:Session 1 Annex 1 & ISO 14644 Updates Session 2 Data IntegritySession 3 Efficacy Testing Please tick which 2 sessions you would like to attend

1st Delegate 1 2 3 2nd Delegate 1 2 3

NOTE: *Euro fee is higher to cover conversion rates

Booking Form and Hotel Information

Note: Fees must be paid by Friday April 29th 2016 in order to guarantee a place(s) at the Conference or one-day meeting

Note: Fees for both meetings include lunch, refreshments and documentation. Fees do not include accommodation, which must be booked and paid for directly with the hotel.

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.

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.A limited number of bedrooms have been reserved at a special rate of @125 for overnight delegates (please book early to avoid disappointment).

Call The Fota Island Hotel and Spa on + 353 21 488 3700 - please quote Pharmig to ensure you receive thediscounted 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 or by email: Maxine@pharmig.org.uk

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.

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