• Risk Management Basics
• The ISO 31000 global risk management process model
• Current Risk Management initiatives (ICH, FDA, ISO etc.) and regulatory expectations
• Why do Risk Management attempts fail?
• Benefits of a Risk Management Program
• Introduction to A System Approach to Total Life Cycle Risk Management
• Effective Risk Management Process:
• Hazard Identification
• Risk Characterization
• Risk Estimation
• Risk Evaluation
• Risk Controls
• Critical Control Point Analysis
• Residual Risk
• Monitoring and Feedback
• Risk Assessment Tools:
• Process Mapping
• Hazard Analysis and Critical Control Points (HACCP)
• Hazard Operability Analysis (HAZOP)
• Fault Tree Analysis (FTA)
• Cause and Effect Analysis
• Failure Mode Effects Analysis (FMEA) etc.
• Risk Management Principles
• Risk Review
• Risk Acceptability
• Risk Communication
• Risk Control
• Effectiveness of Risk Control
• Integration of Risk Management with Quality Management
• Risk Management Plan (RMP)
• Corrective and Preventative Actions
• Composing scientific justifications
• Effectiveness evaluation
• Risk Management Audit

Mr. Edwin L. Bills Principal Consultant Bilanx Consulting, LLC

During his 20 year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. He is also Regulatory Affairs Certified through the Regulatory Affairs Professionals Society, and obtained a Bachelor of Science and Masters degrees from the University of Cincinnati.

Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical device participated in the development of ISO 14971 risk management standard for medical devices. Mr. Bills is a current member of the US national committee on medical device risk management and the US national committee on quality systems.

Mr. Bills has presented training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems, and presented courses at the University of Southern California and the University of Washington in their regulatory affairs graduate programs. He has also authored several articles on medical device risk management. Currently, Mr. Bills is the Principal Consultant at Bilanx Consulting LLC, in the area of medical device quality, regulatory, product liability and risk management.

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Mr. Steven Weitzel VP Technical Operations Critical Process Cleaning CANI Inc.

Mr. Weitzel is frequent industry speaker on such topics as process validation, change control, and validation master plans which all involve emphasis on a risk based approach, integrating elements of Process Analytical Technologies and cGMPs for the 21st Century initiatives. He is also a recognized expert on cleaning validation, microbial control and monitoring, and contamination control for aseptic manufacturing, biotech, drug and medical device manufacturing. Current responsibilities include technical and quality systems management for CANI, Inc. The company offers a full range of technical and validation services related to cleaning and microbial control, as well as chemical agents, decontamination services, and applications for Novaflux, a revolutionary 2-phase cleaning technology that reduces water and chemical use by 90%. He earned a B.S. in chemical engineering from the University of Missouri, and a Masters in Business Administration from Washington University in St. Louis. He has over 20 years experience in FDA regulated industry in, engineering, operations, validation and technical marketing at Dow Chemical, Mallinckrodt, and divisions of Merck and Bristol-Myers Squibb. He has conducted technical training or consulted for the world's leading pharmaceutical, biotech and medical device companies and made numerous technical presentations. He is a member of the PDA and ISPE.

Tuesday March 30, 2010 08:00 AM Registration and Continental Breakfast 08:30 AM Risk Management Basics (ISO 31000) 10:30 AM Mid-Morning Refreshment Break 10:45 AM Course Continues 12:15 AM Luncheon 1:30 PM Course Continues 3:45 PM Mid-Afternoon Refreshment 4:00 PM Course Continues 5:00 PM Questions & Answers 5:15 PM Conclusion of Day 1

Wednesday March 31, 2010 8:00 AM Continental Breakfast 8:30 AM Course Continues 10:45 AM Mid-Morning Refreshment Break 11:00 AM Course Continues 12:45 PM Luncheon 1:45 PM Course Continues 3:15 PM Mid-Afternoon Refreshment 3:30 PM Course Continues 5:00 PM Questions & Answers 5:15 PM Conclusion of Program

The ISO 31000 global risk management process model Current Medical Product Risk Management initiatives (ICH Q9, FDA Guidance, GHTF Guidance, ISO 14971 etc.) and regulatory expectations Similarities and differences between medical product risk models ISO14971 ICH Q9 New device standards including Risk Management IEC 80001 IEC 80002 ISO 10993-1 ISO 14155 IEC 60601-1 3rd Edition Amendment 1 (Proposed) Regulatory expectations FDA-CDRH FDA-CDER, CBER and Combination products ISO 13485 and Rest of World EU Medical Device Directive This presentation is designed to discuss the various risk models and how a company can use their similarities to develop their own model that complies with various regulations and standards that require the medical product industries to use risk management to improve product safety

Workshop Why do Risk Management attempts fail?

Focus on Risk Tools not product/process risk Format vs. content Wrong team at wrong time Product, Process, Medical knowledge vs. Compliance Closed book vs. Continuous learning There are organizational and group dynamic issues ,and gaps in the level and type of detail in understanding and expertise that can result in ineffective risk assessment or misdirected risk mitigation and control. Ineffective in controlling risk now, or ineffective in addressing new scenarios.

Group Presentations Benefits of a Risk Management Program

New Product or Process launch Existing Process Process/Product Improvement Understanding leads to focus on what is important for risk control freeing resources spent on activities that do not add value. This has benefits in all phases: Reduction of redundant OQ, PQ, PV activities; faster, cheaper technology transfer Fewer inspections; less sampling and intervention; fewer deviations, faster resolution when you have them Reduction of QC sampling analysis in favor of process indicators Better response, resolution of deviations/OOS; fewer batches in jeopardy Intelligent change control evaluation avoids fear of change and promotes continuous improvement and cost control.

Introduction to A Systems Approach to Total Life Cycle Risk Management

Product Life cycle Process Life Cycle Validation Life Cycle Risk Management is not a stand-alone activity. Risk based approach to product and process understanding, control and validation should be integral to all key functions: Product Development Process Development and scale-up Licensing and commercial operations Product and process improvement As the knowledge base grows, cause and effect and risk potential are better understood and processes can be fine-tuned to save resources without increasing risk of deviations.

Effective Risk Management Process:

Hazard Identification Risk Characterization Risk Estimation Risk Evaluation Risk Controls Critical Control Point Analysis Residual Risk Monitoring and Feedback All Risk Management models include the basic process steps. The question for industry is in implementation of the steps to provide an effective process. Here some basic recommendations for implementing an effective process will be presented.

Group Case Exercise Risk Assessment Tools:

Process Mapping Hazard Analysis and Critical Control Points (HACCP) Hazard Operability Analysis (HAZOP) Fault Tree Analysis (FTA) Cause and Effect Analysis Failure Mode Effects Analysis (FMEA) etc. Various tools have been developed in various industries to review, evaluate and quantify risk. Understanding the tools will provide insight on how to make risk evaluation more systematic. It will also help guide selection of a combination of tools and techniques appropriate for the particular product or scenario.

Group Case Exercise Risk Management Principles

Risk Review Risk Acceptability Risk Control Effectiveness of Risk Control Risk Communication Quality Risk evaluation is basically understanding the likelihood of deviation or defect (and why) weighted by the severity of adverse effect if it occurs (and why). Basic principles should guide how a risk based approach is integrated into quality and operations systems.

Interactive Session Integration of Risk Management with Quality Management (GHTF)

Risk Management Plan (RMP) Development Purchasing Production Corrective and Preventative Actions Effectiveness evaluation Risk Management Audit This presentation includes some example forms and flow charts for an integrated risk management and quality system. Manufacturers can use this presentation to guide their improvements in developing a compliant risk management process fully integrated into the quality system. Using the Risk Traceability Summary to document Risk Management activities during design, production Examining Risk Management requirements for each phase of the product lifecycle and post-production. Identifying documentation requirements for Risk Management. Developing forms and reports that provide objective evidence of risk management compliance. Integrating Postmarket Risk Management activities with CAPA How FDA's Health Hazard Evaluation relates to Risk Management How Risk Management Tools relate to documentation of Risk Management activities

This two day conference is directed toward Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biopharmaceutical and allied industries with responsibilities in the follow areas:

• Risk Management and Risk Assessment
• Quality Assurance
• Quality Control
• Process Management
• Analytical Development
• R&D
• Design and Formulation
• Manufacturing
• Formulation
• Validation
• Engineering
• Statistics
• Regulatory Affairs
• Technical Services
• Project Management
• Operations
• Production
• Product Submission
• Clinical Research
• Documentation and Technical Writing
• Product Development
• Training
• Consultants

 

Registration Fee Includes: Presentation Materials, Luncheon, and Refreshments

Cancellation/Substitutions Policy:

All cancellations are subject to a USD $150.00/person processing fee. To receive cancellation credits for attendance at an upcoming course, IPA must be notified of the cancellation in writing (by email, mail or fax) up to 3 weeks prior to the program start date. Cancellations submitted less than 3 weeks prior to the event will not be qualified for refund or credit. Substitution of delegate/s with the member/s of the same organization is permitted at any time with no penalty.

IPA reserves the right to postpone an event, prior to which time all the registered attendees will be notified a minimum of 2 weeks in advance. IPA shall not be responsible for any air fare, hotel or transportation costs incurred by registrant/s.

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