Attend and hear about:• Data Integrity – New Expectations

• The Use of Rapid Microbiological Methods

• Annex 1 Updates

• Transfer of Microbiological Methods between Laboratories

• Microbiological Monitoring & Control in Sterile Compounding

• Pseudomonas and Water: A Practical Insight

• The use of HACCP for Reducing Microbiological

Contamination

• The Potential Impact of Brexit!

• And more…!

Latest Updates and Hot Topics in Microbiology

Andrew Hopkins MHRA

Laura Guardi AstraZeneca

Anna Lovatt GlaxoSmithKline

Edel Fitzmaurice Fitzmaurice Scientific Ltd

Peter Gough NSF Health Sciences Pharma Biotech Consulting

Julie Roberts J Roberts Associates

Bharat PatelPublic Health England

Paul NewbyGlaxoSmithKline

Tony CundellMicrobiological Consulting LLC (USA)

Leading microbiology experts include:

Early Bird OfferSending 2 people?

Book before the 7th October and

the second delegate receives a 25% discount

on listed prices

24th Annual Event

PLUS Special

discounts for NHS See booking page

for further details

Venue: The Nottingham Belfry Hotel, Mellors Way, Off Woodhouse Way, Nottingham, NG8 6PY

Date: 16th &17th November 2016

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 Key Note: Annex 1 Update and Common Inspection Deficiencies for Sterile Manufacture

• Draft Annex 1 progress and next steps • Key changes • Sterile manufacturing inspection, key

deficiencies and approaches taken by the MHRA inspector

Andrew Hopkins, Expert GMDP Inspector - MHRA

10.00 – 10.45 Data Integrity and New Expectations • Data integrity within the microbiology

laboratory • 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

10.45 – 11.30 Meet the exhibitors over tea & coffee

11.30 – 12.15 Microbiological Monitoring and Control in Sterile Compounding

• What is sterile compounding and how is it regulated in the United States?

• Overview of the New England Compounding Centre fungal meningitis outbreak

• Microbial risk analysis of compounded sterile preparations

• Facility design, control and monitoring practices

• Sterility and bacterial endotoxins testing of compounded sterile preparations

• Opportunities for the application and alternative sterility tests

Tony Cundell - Consulting Microbiologist, Microbiological Consulting LLC (USA)

12.15 – 13.00 Open Discussion Sessions

13.00 – 13.30 Pharmig AGM All Members please do attend. 13.30 – 14.30 Finger buffet lunch in the Exhibition Area

14.30 – 15.10 The Use of Rapid Microbiological Methods (RMM)

• Background to RMM implementation and application within GSK

• Validation considerations • Candidate technologies • Some issues and challenges • Key messages

Paul Newby – SM Manager, GlaxoSmithKline

15.10 – 15.40 Transfer of Microbiological Methods between Laboratories

• GMP Chapter 6 • Supplier approval / contracts and technical

agreements • Method transfer protocols • What you should watch out for! Dr. Kevin Wright - Principal Scientist

Microbiology Capability Organisation, Procter & Gamble Company (UK)

15.40 – 16.00 Tea & coffee with the exhibitors

16.00 – 16.50 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! • The importance of this venue in-terms of

water quality! Bharat Patel – Consultant Medical Microbiologist, PHE (Public Health England)

Latest Updates and Hot Topics in MicrobiologyWednesday 16th November 2016

24th Annual Event Latest Updates and Hot Topics in Microbiology2

24th Annual Event Latest Updates and Hot Topics in Microbiology

09.00 – 09.05 Chair’s Opening Remarks and Champagne Draw

09.05 – 09.45 Bioburden Control in the Manufacture of Non-sterile Drug Products

• Critical quality attributes of non-sterile products: microbial count, absence of specified microorganisms, and absence of objectionable microorganisms

• Risk hierarchy by dosage form • Role of formulation and product attributes • Role of facility design and unit processing

steps • Risk mitigation steps • Case histories of microbial contamination Tony Cundell – Consulting

Microbiologist, Microbiological Consulting LLC (USA)

09.45 – 10.30 Environmental Monitoring Risk Assessment and the Lean Approach

• Matrix / Surfaces / Coupons • What test methods should be selected

and what are their pitfalls? • Acceptance criteria • Recent examples of warning letters • How to prepare the validation package for

inspection Laura Guardi – Senior QA Auditor, AstraZeneca

10.30 – 11.00 Tea & coffee with exhibitors

11.00 – 11.45 Open Discussion Sessions Continued

11.45 – 12.05 Committee Reporter Feedback / Summary from Discussion Sessions

12.05 – 12.50 Which Microbial Identification System is Best for You?

• A summary of different identification systems available

• Key considerations in choosing a system appropriate for the facility and / or product type

• The importance of understanding your facilities requirements and developing a User Requirement Specification (URS)

Anna Lovatt – Microbiology Manager Oral Health, GlaxoSmithKline

12.50 – 14.00 Finger buffet lunch

14.00 – 14.45 The Use of HACCP for Reducing Microbiological Contamination

• USP <1115> • HACCP key points • HACCP as a risk analysis tool • Risk reduction • Identify key sampling plans and test plans • VACCP (Vulnerable Assessment and

Critical Control Points) and TACCP (Threat Assessment Critical Control Point)

Edel Fitzmaurice – Managing Director, Fitzmaurice Scientific Ltd

14.45 – 15.15 The Potential Impact of Brexit on Pharmaceuticals and Biopharmaceuticals

Pete Gough – Executive Director, NSF Health Sciences Pharma Biotech Consulting

15.15 – 15.30 Summary and Close of Conference

15.30 – 16.00 Departure tea & coffee

Latest Updates and Hot Topics in MicrobiologyThursday 17th November 2016

3

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 16th November 2016 (continued)

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.

Please tick 2 out of the 4 listed below on your booking form

A. Data Integrity Discussion Session Led By: Julie Roberts – J. Roberts Associates Ltd

B. Disinfectant Workshop: Factors to Consider when Designing a Disinfectant Efficacy Test and Interpretation of Results Delegates will be provided with a set of data and asked to develop a rationale for a disinfectant regime and interpretation of results Led By: Laura Guardi, Astra Zeneca & Rachel Blount, Ecolab

C. Pharmig Expert Microbiology Surgery (Sterile & Non Sterile)

Q&A session with Pharmig Committee Members - come armed with your microbiology questions! Led By: Andy Martin, ABM Consulting & Andy Brack, PZ Cussons

D. Culture Media: Back to Basics • Covering testing media and choosing the right media Led By: Dr Tim Sandle, BPL

Please note: all information addressed by the speakers are of their own / company opinions. Pharmig is not responsible for any contentpresented at the meeting.

Pharmig also has the right to change the programme at any time due to unforeseen circumstances.

Discussion Sessions

24th Annual Event Latest Updates and Hot Topics in Microbiology4

Launching Pharmig’s latest Fact Sheet Range

A series of 8 fact sheets on – Cleanroom Environmental IsolatesFollowing on from the previous three sets of fact sheets – ‘Microbial Limits Test’, ‘Objectionable Microorganisms’ and Pharmaceutically Important Fungi Pharmig is pleased to launch the fourth set of fact sheets on Cleanroom Environmental Isolates. This series will cover: Micrococcus luteusStaphylococcus epidermidisBacillus sphaericusAcinetobacter spp.Penicillium chrysogenumAspergillus versicolorMicrococcus lylaeCorynebacterium species

Member price £30Non Member price £50

24th Annual Event Latest Updates and Hot Topics in Microbiology 5

Pharmig would like to thank the following companies who are exhibiting at this years’ conference and for their continuing support.

24th Annual Event Latest Updates and Hot Topics in Microbiology6

REGISTRATION FORM

PHARMIG 24TH ANNUAL CONFERENCE16TH & 17TH NOVEMBER 2016

Please reserve place(s) for Pharmig’s 24th Annual Conference held at The Nottingham Belfry Hotel on the 16th & 17th

November 2016.

Company:

Address : Tel:

Email:

1st Delegate

First Name:

Surname:

Job Title:

2nd Delegate

First Name:

Surname:

Job Title:

Open Discussion Sessions Please tick 2 sessions you wish to attend. 1 2 3 4 Gala dinner (included in fee)

Open Discussion Sessions Please tick 2 sessions you wish to attend. 1 2 3 4 Gala dinner (included in fee)

ACCOMMODATION AT THE PREMIER INN NOTTINGHAM WEST HOTEL ONLY (PLEASE SEE ACCOMMODATION NOTES FOR A DETAILED EXPLANATION)

DELEGATE 1: I wish to add to the invoice £70 B&B per night at this hotel: 15th November 16th November

ACCOMMODATION AT THE PREMIER INN NOTTINGHAM WEST HOTEL ONLY

DELEGATE 2: I wish to add to the invoice £70 B&B per night at this hotel: 15th November 16th November

Email or fax your completed booking form for a confirmed place:

Email: info@pharmig.org.uk Fax: to +44 (0) 1920 871 156

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)

Please state any specific dietary requirements:

Delegate 1

Delegate 2

24th Annual Event Latest Updates and Hot Topics in Microbiology 7

PHARMIG 24TH ANNUAL CONFERENCE16TH & 17TH NOVEMBER 2016

Maxine Moorey PharmigT5 The MaltingsRoydon RoadStanstead AbbottsHertfordshire, SG12 8HG

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 if staying at the Nottingham Belfry Hotel or, to be added to your Conference fee invoice if you choose to stay at the Premier Inn Nottingham West Hotel.NB: Fees must be paid by Monday 17th October in order to guarantee a place(s) at the Conference. LAST YEAR WAS A SELL-OUT!

PHARMIG MEMBER FEES NON MEMBER FEES Delegate £695 / €830 Delegate £995 / €1180* Euro fee is higher to cover conversion rates * Euro fee is higher to cover conversion rates

Discounted rates are available for NHS and non-profit making organisations NHS Member Fees £350 Non NHS Member Fees £450

ACCOMMODATIONPharmig have secured rooms at two venues this year – please read the following carefully

1. Nottingham Belfry (venue for the 2-day conference) - £105 B&B per person / per night

2. Premier Inn Nottingham West Hotel - £70 B&B per person / per night (8 minute journey to the Nottingham Belfry Hotel by car)

Taxis will be provided by Pharmig to bring anyone staying at the Premier Inn Nottingham West Hotel to the Nottingham Belfry for the gala dinner. (Own travel arrangements will need to be made for the return journey)

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 9421 (state you are booking for the Pharmig Conference to receive the reduced rate). Rooms are non-refundable.

It is advised to book directly with the hotel rather than going through other websites to guarantee your room booking.

VENUE HOTEL ADDRESS:Nottingham Belfry HotelMellors Way Off Woodhouse WayNottinghamNG8 6PY

To book this accommodation – Pharmig has to do this on your behalf. As such please mark on your booking form if you would like Pharmig to invoice you for accommodation at this hotel and – for how many nights (15th & 16th November OR just the 16th November)

Note: cancellations of rooms for this hotel can only be made up until Monday 17th October – after that they are non-refundable.

HOTEL ADDRESS: (8 mins by car to the Nottingham Belfry Hotel)The Phoenix CentreMillenium Way WestNottingham NG8 6AS

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.

CONFERENCE INFORMATION

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