ISPE UK Affiliate Event - 22 November 2012

Attending this year

ABB Consulting

Ardmac Performance 
Contracting Ltd

Astech Projects Ltd

AstraZeneca

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

GlaxoSmithKline

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

Pfizer

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

Siemens

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

Agenda

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