Current Hot Topics in Pharmaceutical Microbiology 18th May 2016

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Presents Current Hot Topics in Pharmaceutical Microbiology 18th May 2016 Control of Pharmaceutical Water Systems 19th May 2016 Leading experts include: Dr Tim Sandle, BPL Bharat Patel, Public Health

Cleat Engineering Discounts apply for each event and for those wanting to attend both OFFERS END 15TH APRIL 2016 Richard Sinden, Suez (see booking form for further information) David Keen,

1 Presents Current Hot Topics in Pharmaceutical Microbiology 18th May 2016 Control of Pharmaceutical Water Systems 19th May 2016 Leading experts include: 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 Discounts apply for each event and for those wanting to attend both OFFERS END 15TH APRIL 2016 Richard Sinden, Suez (see booking form for further information) David Keen, GlaxoSmithKline Venue: Fota Island Hotel, Cork Pharmig T5 The Maltings, Roydon Road, Stanstead Abbotts, Hertfordshire, SG12 8HG, United Kingdom. Tel: +44 (0) Fax: +44 (0) info@pharmig.org.uk Web:

2 Hot Topics In Pharmaceutical Microbiology Wednesday 18th May Registration Chairs Welcome & Introduction 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 &2: 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 wg 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 Meet & Greet the Exhibitors with Tea/Coffee 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 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 Buffet Lunch in Exhibition Area Open Discussion Sessions Open Discussion Session Continued Tea/Coffee in the Exhibition Area Session TBC 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? Manager, GlaxoSmithKline and Programme continued overleaf 2 Hot Topics In Pharmaceutical Microbiology - Wednesday 18th May

Hot Topics In Pharmaceutical Microbiology Continued Wednesday 18th May 2016 16.40-16.

hosting a small drinks reception this evening 7pm 8pm. Delegates will need to make their own dinner arrangements at the hotel.

Session 1 Annex 1 and ISO 14644 Updates Led by: G ordon Farquharson Director & Principle Consultant, Critical Systems (TBC) & Dr.

3 Hot Topics In Pharmaceutical Microbiology Continued Wednesday 18th May 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. Open Discussion Sessions Tuesday 19th May 2015 Please choose 2 out of the 3 listed and mark accordingly on your booking form. Session 1 Annex 1 and ISO Updates Led by: G ordon 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 Hot Topics In Pharmaceutical Microbiology - Wednesday 18th May 3

4 Control of Pharmaceutical Water Systems Thursday 19th May 2016 Fota Island, Cork Registration with Tea/Coffee Chairs Introduction 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) Current Hot Topics and Common Audit Citations in Water Edel Fitzmaurice - Managing Director, Fitzmaurice Scientific Ltd Morning Break with Tea/Coffee Water Systems Operation Maintenance Disinfection Critical parameters Design & qualification Lee Eyres Owner, Crystal Clear Engineering 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 Lunch Control and prevention Regulatory factors and timelines Richard Sinden - Life Sciences Product Innovation and Regulation Director, Suez 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 Purified Water Systems What can a purified water system consist of? Microbial risks of a purified water system Afternoon break with Tea/Coffee 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! Summary & Chair s Closing Remarks 4 Control of Pharmaceutical Water Systems - Thursday 19th May 2016

5 Booking Form and Hotel Information Please circle the relevant meeting fee (s) outlined in Booking Form A, B or C below BOOKING FORM A Hot topics in Pharmaceutical Microbiology Tuesday 19th May 2015 Member Fees Non Member Fees 1st Member - e650 / 495 1st Non Member - e910 / 695 2nd Member - e525 / 395 2nd Non Member - e780/ 595 Send 2 or more people from the same company and receive a discount on the full price as outlined above HURRY! DISCOUNTED OFFERS END 15 TH APRIL 2016 DISCUSSION SESSIONS: Session 1 Annex 1 & ISO Updates Session 3 Efficacy Testing Session 2 Data Integrity Please tick which 2 sessions you would like to attend 1st Delegate nd Delegate BOOKING FORM B Control of Pharmaceutical Water Systems Thursday 19th May 2016 Member Fees Non Member Fees 1st 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 Fees 1st Member - e975/ 745 1st Non Member - e1485 / nd Member - e715 / 545 2nd Non Member - e1230 / 945 NOTE: *Euro fee is higher to cover conversion rates 1st Delegate First Name: Surname: Job Title: Company Name: Address: 2nd Delegate First Name: Surname: Job Title: Company Name: Address: Dietary Requirements: Dietary Requirements: Cheques should be made payable to Pharmig and attached to this form for a confirmed place or fax / this booking form to +44 (0) / 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) Booking Form and Hotel Information 5

6 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 for overnight delegates (please book early to avoid disappointment). Call The Fota Island Hotel and Spa on please quote Pharmig to ensure you receive the discounted 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 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) Fax: +44 (0) info@pharmig.org.uk Web:

Requirements for a GMP-compliant Data Life Cycle May 2016, Berlin, Germany. Karl-Heinz Menges Regierungspräsidium Darmstadt

Data Integrity Workshops on: Analysis of FDA Warning Letters Key Data Integrity Topics / Criteria Assessing a System for Data Integrity Requirements for a GMP-compliant Data Life Cycle 17-19 May 2016,