ISPE UK Affiliate Event - 22 November 2012

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Competitive Advantage from Risk Based Approaches

22 November 2012 - Harrogate Majestic Hotel and Harrogate International Centre - Harrogate



Time is running out to book your place at our Annual Seminars!  Please take a moment to look at the full agenda below.  We have just added abstracts for a Case Study on Applying E-2500 by NNE Pharmaplan, and Risk Based Cleaning for Multi Product Biologics Manufacture by Fujifilm Diosynth Biotechnologies.  

two new speakers: Alison Justice, Head of Quality at Eden Biodesign will share her experience of risk based approaches to product development of biologics, and Steve Davy of Biogen Idec will present a case study of a new risk tool applied to a monoclonal antibody process.  We have worked hard to fill the day with plenty of Case Studies from Pharma and Biopharma Manufacturers, describing the benefits they have achieved by applying Risk Based Approaches. The companies leading the way in applying these techniques are seeing real benefits to the bottom line, as well as improving quality, safety, productivity and plant reliability.    For Non-Members we are also able to offer a special deal. By registering for the conference and becoming an Industry Member of ISPE at the same time, you will save £55 on registration and $40 on membership. Just register for “Join and Save”. 



Attending this year


ABB Consulting

Ardmac Performance 
Contracting Ltd

Astech Projects Ltd


Biopharma Process Systems Ltd

Biogen Idec

Boulting Environmental Services

Boulting Group Ltd

Camfil Limited

Centec UK

Cobra Biologics

Compliance and

Validation Services

Davis Langdon Aecom

Eden Biodesign Ltd

Energy and Carbon Reduction Solutions Ltd

Eurotherm Ltd

Eutech Validation Ltd

Extract Technology Ltd

Faithful + Gould

Fujifilm Diosynth Biotechnologies


Grove Lodge Consulting Limited

Hosokawa Micron Limited

Howorth Air Technology

ILC Dover

Industrial Technology Systems Ltd

Interserve Construction Limited

John Sisk and Son Ltd

Johnson Controls

M + W Group

Mach-Aire Limited

Merit Merrell Technology Limited

Mott MacDonald Group Ltd

NNE Pharmaplan

Pall Europe Limited

Parker Hannifin Limited


Pharmadule Morimatsu AB

PM Group

Protel Associates Ltd

Romaco FrymaKoruma

S3 Process Limited

Sartorius Stedim UK Limited

SCA Nutech

SciTech Engineering

Service Design Partnership Ltd

Shepard Engineering Services


Step Change Pharma

Sweett Group

The Austin Company of UK Ltd

TSL Projects Ltd

Vaisala OYJ

WH Partnership Ltd

Williams Process Ltd

WSP CEL Limited

Ytron - Quadro (UK) Ltd

Costs for attending


Conference places







OR £140 with "Join and Save"

when you join at the offer price of $199.00 or €170.00




Exhibition space    

Exhibitor delegate






Awards dinner places


Individual place      

Tables for 10 guests     

Tables for 12 guests 






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Credit & Debit cards only,

fee is payable





Registration, Coffee, Exhibition & Networking 
- from 8:00am

Welcome and Introduction - 9.25am

How to Implement Process Validation to Facilitate Performance Improvement

Ali Afnan, President, Step Change Pharma 
(formerly of FDA

Our health depends on a prosperous and trusted 
pharmaceuticals industry with a robust supply 
chain of new and existing products. Yet a perceived 
absence of new chemical entities as well as 
"block-busters" is challenging the industry. 
Increasing recalls and financial penalties for 
unacceptable practices have eroded consumer confidence. Drug shortages are at an all-time high, with consumers demanding revocation of manufacturing licenses and opening the products 
to the generics markets. Changing its "current thinking"  dramatically, the FDA released a guidance on process validation, and the European regulators seem to be aligning their thinking with the FDA. Will this guidance enable industry to address the above issues; or will it be another burden adding to the woes of the industry?

Risk Analysis and Mitigation Matrix (RAMM) – A Risk Tool for Quality Management

Steve Davy, Biogen Idec

The presentation of a new risk tool.  Risk Analysis and Mitigation Matrix (RAMM) was developed to be incorporated into a modern risk management system and align with latest FDA guidelines.  A case study is discussed in the use of RAMM for a mAb process.

E2500 – The New Approach to Validation

Henrik Feldthusen and Brian Andreasen -NNE Pharmaplan

Communicating the Risk and Uncertainty of Process and Product Development

Gill Turner, Quality by Design Lead,GlaxoSmithKline

In process and product development the key challenge is managing risk in the face of uncertainty. This talk will focus on the distinction between the management of quality and business risk prior to transfer to manufacturing and regulatory submission. Which risks do we choose to accept, which do we need to control and if we need to do further work to mitigate risk or uncertainty, when do we need to do this? Risk management is not an exact science; different teams and individuals interpret risk and procedures for risk management in different ways. What are the important principles we adopt when discussing our risk decisions with manufacturing colleagues and external regulators?

Risk Based Approaches for Early Phase Clinical Development and Manufacture of Biologics 

Alison Justice, Head of Quality,Eden Biodesign

ISPE Risk-MaPP Guide, Quantitative Risk Assessments and Containment

– How do we take it to the next stage?

Peter Marshall, Principal Technology Engineer, AstraZeneca


Understanding the emergence of potent materials and their impact on implementing risk based approaches to cross contamination is becoming a major issue in pharmaceutical manufacture and production facility specification.  The paper will look at the background of RISKMAPP and cross contamination QRAs, and options and issues with different approaches, with particular reference to application of containment and other exposure control systems.

ISPE Project Management Guide: An Integrated Risk Management Approach with Case Study

Alf Penfold, Director,Pfizer Global Engineering

The new ISPE Project Management Guide contains a lot of useful information on an integrated risk management approach. For example, it includes risks to the project, the process and product. It covers the process of applying a risk-based approach across the project life cycle and how this links in with regulatory requirements. The importance of risk management for each project stage is considered along with some of the different tools and approaches available and their suitability for use. For example, risks associated with a project, product quality or patient safety may require a different tool or approach. The new guide includes many examples and case studies. An additional case study will be presented to re-enforce the benefits of an integrated risk management approach.

A Risk Assessed Approach to Life Cycle Management of Pharmaceutical Assets

Dr Phillip Richardson, Director Asset Life Cycle Management Europe, AstraZeneca

Many pharmaceutical companies are struggling to manage their asset base effectively for long term benefit in a climate of falling revenues and increasing regulatory demands. The paper will describe a risk assessed approach that helps clarify investment and operating decisions in this difficult environment.

Risk Based Cleaning for Multi Product Biologics Manufacture

Dr Kit Erlebach, Fujifilm Diosynth Biotechnologies

Final Remarks and Conference Close - 4.30pm

Annual Awards Dinner at Harrogate International Centre


Drinks Reception from 6.15pm 


Awards - 7.15pm


Dinner - 8:00pm


After dinner speaker - John Moloney

Twice winner of the Best Live Performer award at the London Comedy Festival, who makes regular TV appearances, and writes for Jack Dee, Harry Hill and many others.


Networking until midnight




For more information please contact:


Dr Peter Dodd, Fujifilm Diosynth Biotechnologies

Chairman, ISPE UK Affiliate Northeast Region

+44 (0)1642 364 032


Bruce Williams, Williams Process Ltd

Chairman, ISPE United Kingdom Affiliate Ltd

+44 (0)7944 766 508


How to book

•           Phone +44 (0)1489 571213 

•           email

•           Download word document booking form click here ( 45 KB)

•           Book on line click here credit and debit cards only (fee payable)