Applied Risk Management – Addressing Cross Industry Challenges

1–2 December 2008
Barcelona, Spain

Seminar leaders
Trish Melton, MIME Solutions Ltd (UK)
Jörg Block, Bayer HealthCare AG (Germany)

Thorough overview of risk management issues – covering many aspects of the pharmaceutical product lifecycle
An introduction to ISPE’s new Risk-MaPP Baseline^® Guide
A take-home "tool kit" of useful techniques, concepts and case studies

Risk management is a process used within most areas of the pharmaceutical and biopharmaceutical industry - whether it is assessing the risks in developing or manufacturing a new drug, or the risks when building facilities to produce drugs. Within the pharmaceutical industry, a vast array of potential risks need to be identified, eliminated or mitigated - and ultimately controlled. Our goal is to take a risk-based approach to all aspects of the drug product lifecycle: from development to launch; from launch to sustainable manufacture.

This seminar will introduce general principles of risk management which are applicable across the industry and aims to be a practical workshop introducing different risk types and challenges, including quality (ICH Q9); project (cost, time and scope risks); operational (risks associated with health and safety, containment, maintenance and quality); business (supply chain, commercial and competitive risks).

Speakers include leaders in the field of risk management, and subject matter experts from ISPE Communities of Practice (COPs). During interactive sessions, speakers will present concepts, tools and case studies and offer hands-on practice in applying these.

Take Back To Your Job

Familiarity with the generic concepts of risk management applicable in all areas of risk assessment – from quality to safety
The ability to apply generic risk management concepts and tools – introduced and explained during the seminar
A take-home "tool kit" for risk management – including tools, techniques, templates and sample model answers

Agenda

Monday, 1 December

10.00 – 10.05 Welcome and Introduction
Trish Melton, MIME Solutions (UK)

10.05 – 11.00 A Risk-based Approach to the Pharmaceutical Product Lifecycle
Damian Greene, Pfizer (tbc)

Broad overview of the risks at each stage in the product lifecycle from product development through launch to sustainable supply
The strategic importance of risk management to our industry and to our business

11.00 – 11.45 Quality Risk Challenges – An Overview of ICH Q9
Malcolm Holmes, Retired (UK)

An overview of ICH Q9 and why this is needed within our industry: The history and the benefits
Quality risk assessment: The process, key principles and examples of tool use in specific scenarios within the pharmaceutical industry

11.45 – 12.30 Risk Management Techniques – An Introduction
Trish Melton, MIME Solutions (UK)

An introduction to generic risk management – process and principles
The introduction of some generic tools and techniques and when each can be used, e.g., risk matrices and decision tools, FMEA, Ishikawa, HACCP, etc
Delegates will have an opportunity to complete a brief exercise using a ‘what if’ risk technique

12.30 – 14.00 Lunch and Networking Break

14.00 – 15.30 Project Risk Management
Jim Durkin, Advanced Medical Solutions (UK)

Introduction to typical cost, time and scope risks
Interaction with other functions and links to business risk
The application of SWOT analysis and the risk table and Matrix in a project situation
Introduction of a case study and tool template which delegates will use to address project risks

15.30 – 16.00 Coffee and Networking Break

16.00 – 17.30 Containment Risk Assessment – Risk-MaPP Baseline Guide
Malcolm Holmes, Retired (UK)

An introduction to ISPE’s new Risk-MaPP Baseline Guide
Introduction to holistic approach to management of risks presented to patient/operator from pharmaceutical compounds handled in a pharmaceutical manufacturing environment
Introducing some of the tools such as process mapping, cause and effect diagrams, logic diagrams and HAZOP and how these assist in managing exposure risks
Introduction of a case study and tool template which delegates will use to address exposure risks

17.30 – 17.45 Questions and Answers, Close of Day 1
Trish Melton, MIME Solutions (UK)
Jörg Block, Bayer HealthCare AG (Germany)

17.30 – 18.30 Networking Reception

Tuesday, 2 December

09.00 – 9.15 Review of Day 1, Introduction to Day 2
Jörg Block, Bayer HealthCare AG (Germany)

09.15 – 10.45 Risk Management in the Manufacturing Lifecycle
Roberto Correa, Bayer HealthCare (Germany)

Introduction to the risks in manufacturing operation and maintenance – safety, quality and business
Application of the ICH Q9 risk management process to quality, safety and business risks using a simplified FMEA approach
Introduction of a case study and tool template which delegates will use to review manufacturing risks

10.45 – 11.00 Coffee and Networking Break

11.00 – 12.30 The Risk-based Approach in Commissioning and Qualification (C&Q)
Jörg Block, Bayer HealthCare AG (Germany)

Introduction of C&Q in terms of its approach to risk management and how techniques such as HACCP and Ishikawa analysis can be used
Introduction of a case study and tool template which delegates will use to address the critical aspects of C&Q

12.30 – 13.30 Lunch and Networking Break

13.30 – 15.00 Efficient Risk Assessment for Computer Systems using GAMP^® 5
Hartmut Hensel, Fachhochschule Harz (Germany)

Application of the GAMP 5 risk management process for initial system risk assessment considering the software impact on product quality
The application of risk checklists on a fault tree basis
Introduction of a case study and tool template for diversified software systems

15.00 – 16.15 An Approach to Risk Management in API Facility Design
John Nichols, Retired (UK)

An introduction to the risk management approach outlined in the revised API Baseline Guide (launched in June 2007)
Using risk flow charts and associated checklists to define critical parameters and levels of protection
Introducing two additional risk techniques to support the assessment of ‘briefly open’ to address exposure risks from a quality perspective – FMEA and HACCP
Introduction of a case study and tool template which delegates will use to address the risks of an exposed API operation

16.15 – 16.40 Risk Management Master Class
All speakers of days 1 and 2, chaired by Trish Melton, MIME Solutions (UK)

An opportunity for the delegates to ask the experts about specific risk management issues

16.40 – 16.45 Questions and Answers, Close of Seminar
Jörg Block, Bayer HealthCare AG (Germany)
Trish Melton, MIME Solutions (UK)


Conference Programme General Information Venue and Area Information Networking Evening Sponsorship Opportunities Table Top Exhibition Registration Information Download Brochure Current as of 18 August Delegates See the company and country background of already registered delegates !	Applied Risk Management – Addressing Cross Industry Challenges 1–2 December 2008 Barcelona, Spain Seminar leaders Trish Melton, MIME Solutions Ltd (UK) Jörg Block, Bayer HealthCare AG (Germany) Thorough overview of risk management issues – covering many aspects of the pharmaceutical product lifecycle An introduction to ISPE’s new Risk-MaPP Baseline^® Guide A take-home "tool kit" of useful techniques, concepts and case studies Risk management is a process used within most areas of the pharmaceutical and biopharmaceutical industry - whether it is assessing the risks in developing or manufacturing a new drug, or the risks when building facilities to produce drugs. Within the pharmaceutical industry, a vast array of potential risks need to be identified, eliminated or mitigated - and ultimately controlled. Our goal is to take a risk-based approach to all aspects of the drug product lifecycle: from development to launch; from launch to sustainable manufacture. This seminar will introduce general principles of risk management which are applicable across the industry and aims to be a practical workshop introducing different risk types and challenges, including quality (ICH Q9); project (cost, time and scope risks); operational (risks associated with health and safety, containment, maintenance and quality); business (supply chain, commercial and competitive risks). Speakers include leaders in the field of risk management, and subject matter experts from ISPE Communities of Practice (COPs). During interactive sessions, speakers will present concepts, tools and case studies and offer hands-on practice in applying these. Take Back To Your Job Familiarity with the generic concepts of risk management applicable in all areas of risk assessment – from quality to safety The ability to apply generic risk management concepts and tools – introduced and explained during the seminar A take-home "tool kit" for risk management – including tools, techniques, templates and sample model answers Agenda Monday, 1 December 10.00 – 10.05 Welcome and Introduction Trish Melton, MIME Solutions (UK) 10.05 – 11.00 A Risk-based Approach to the Pharmaceutical Product Lifecycle Damian Greene, Pfizer (tbc) Broad overview of the risks at each stage in the product lifecycle from product development through launch to sustainable supply The strategic importance of risk management to our industry and to our business 11.00 – 11.45 Quality Risk Challenges – An Overview of ICH Q9 Malcolm Holmes, Retired (UK) An overview of ICH Q9 and why this is needed within our industry: The history and the benefits Quality risk assessment: The process, key principles and examples of tool use in specific scenarios within the pharmaceutical industry 11.45 – 12.30 Risk Management Techniques – An Introduction Trish Melton, MIME Solutions (UK) An introduction to generic risk management – process and principles The introduction of some generic tools and techniques and when each can be used, e.g., risk matrices and decision tools, FMEA, Ishikawa, HACCP, etc Delegates will have an opportunity to complete a brief exercise using a ‘what if’ risk technique 12.30 – 14.00 Lunch and Networking Break 14.00 – 15.30 Project Risk Management Jim Durkin, Advanced Medical Solutions (UK) Introduction to typical cost, time and scope risks Interaction with other functions and links to business risk The application of SWOT analysis and the risk table and Matrix in a project situation Introduction of a case study and tool template which delegates will use to address project risks 15.30 – 16.00 Coffee and Networking Break 16.00 – 17.30 Containment Risk Assessment – Risk-MaPP Baseline Guide Malcolm Holmes, Retired (UK) An introduction to ISPE’s new Risk-MaPP Baseline Guide Introduction to holistic approach to management of risks presented to patient/operator from pharmaceutical compounds handled in a pharmaceutical manufacturing environment Introducing some of the tools such as process mapping, cause and effect diagrams, logic diagrams and HAZOP and how these assist in managing exposure risks Introduction of a case study and tool template which delegates will use to address exposure risks 17.30 – 17.45 Questions and Answers, Close of Day 1 Trish Melton, MIME Solutions (UK) Jörg Block, Bayer HealthCare AG (Germany) 17.30 – 18.30 Networking Reception Tuesday, 2 December 09.00 – 9.15 Review of Day 1, Introduction to Day 2 Jörg Block, Bayer HealthCare AG (Germany) 09.15 – 10.45 Risk Management in the Manufacturing Lifecycle Roberto Correa, Bayer HealthCare (Germany) Introduction to the risks in manufacturing operation and maintenance – safety, quality and business Application of the ICH Q9 risk management process to quality, safety and business risks using a simplified FMEA approach Introduction of a case study and tool template which delegates will use to review manufacturing risks 10.45 – 11.00 Coffee and Networking Break 11.00 – 12.30 The Risk-based Approach in Commissioning and Qualification (C&Q) Jörg Block, Bayer HealthCare AG (Germany) Introduction of C&Q in terms of its approach to risk management and how techniques such as HACCP and Ishikawa analysis can be used Introduction of a case study and tool template which delegates will use to address the critical aspects of C&Q 12.30 – 13.30 Lunch and Networking Break 13.30 – 15.00 Efficient Risk Assessment for Computer Systems using GAMP^® 5 Hartmut Hensel, Fachhochschule Harz (Germany) Application of the GAMP 5 risk management process for initial system risk assessment considering the software impact on product quality The application of risk checklists on a fault tree basis Introduction of a case study and tool template for diversified software systems 15.00 – 16.15 An Approach to Risk Management in API Facility Design John Nichols, Retired (UK) An introduction to the risk management approach outlined in the revised API Baseline Guide (launched in June 2007) Using risk flow charts and associated checklists to define critical parameters and levels of protection Introducing two additional risk techniques to support the assessment of ‘briefly open’ to address exposure risks from a quality perspective – FMEA and HACCP Introduction of a case study and tool template which delegates will use to address the risks of an exposed API operation 16.15 – 16.40 Risk Management Master Class All speakers of days 1 and 2, chaired by Trish Melton, MIME Solutions (UK) An opportunity for the delegates to ask the experts about specific risk management issues 16.40 – 16.45 Questions and Answers, Close of Seminar Jörg Block, Bayer HealthCare AG (Germany) Trish Melton, MIME Solutions (UK)

Applied Risk Management – Addressing Cross Industry Challenges

1–2 December 2008 Barcelona, Spain

Agenda

1–2 December 2008
Barcelona, Spain