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The Trainer
Edwin L Bills
Principal Consultant , Bilanx Consulting LLC |
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Venue and Date
Hyderabad, February 05, 2008
Ahmedabad - Taj Residency
February 07, 2008
Time:
9:30 am - 5.30 pm |
| Who Will Benefit: |
- Risk Management personnel
- Design and Development personnel
- Regulatory Affairs staff
- Quality Management
- Quality Engineering
- Manufacturing Engineering
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| Trainer Profile : |
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Edwin L Bills, is the
Principal Consultant, Bilanx Consulting LLC,
He has over 20 years experience in the field of quality and regulatory affairs.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 devices and is a current member of the committee.
Currently he is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management.Mr. Bills has also provided expert services to legal counsel in the area of risk management and FDA compliance. |
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Pharmaceutical and Medical Device Risk Management -
Implementing a Risk Management Process in Compliance with ICH Q9 and ISO 14971:2007
As part of Global Compliance Series of seminars, ComplianceOnline brings you the expert view on “Pharmaceutical and Medical Device Risk Management - Implementing a Risk Management Process in Compliance with ICH Q9 and ISO 14971:2007” by Edwin L Bills is the
Principal Consultant, Bilanx Consulting LLC. This seminar would benifits
personnel from Biomedical industry including medical devices and pharmaceutical developers and manufacturers.
A worldwide initiative to improve biomedical products by the use of risk management techniques has begun. Regulatory agencies have intensified efforts to implement risk management initiatives in product approval processes and inspection processes, and in internal resource management Both the medical device risk management standard, ISO 14971 and the pharmaceutical guidance published by ICH, Q9 are based on the same general risk management processes. This common base allows combination products to be developed and manufactured using common or similar risk management processes, eliminating confusion and duplicate efforts.
This seminar will outline and explain the requirements of the two documents to provide a company with the information needed to develop their risk management system and meet regulatory requirements, while lowering exposure to product safety issues.
OUTLINE OF CONFERENCE
- Overview of ISO 14971 Medical Device Risk Management
- Risk Management Requirements in Other Standards
- Introduction and Scope of the Standard
- Definitions
- Management Responsibilities
- View of the Process
- Integrating into ISO 13485 Quality System
- Overview of ICH Q9 Pharmaceutical Risk Management
- Introduction and Scope of the Guidance
- Definitions
- View of the Process
- Integrating ICH Q9 into ICH Q10 Quality System (and ICH Q8 Product Development)
- Beginning a Risk Management System
- Establishing Risk Policy
- Developing Risk Management Procedures
- Risk Management Planning
- Risk Management during Product Realization
- Beginning the Risk Analysis-Which Tools to Use?
- Intended Use
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- Characteristics Related to Safety
- Developing the Hazards List
- Hazardous Situations
- Estimating the Risk
- Performing the Risk Evaluation
- Performing the Risk Evaluation
- Which Risks Require Control?
- Implementing Risk Control Measures
- Residual Risk and New Hazards
- Overall Residual Risk Evaluation
- Verifying Risk Control
- Verifying Risk Control Effectiveness
- Risk Management Activities Involving Production
- Risk Management Report and Completed Risk Management Summary
- Risk Management Information Disclosure
- Postproduction Risk Management
- CAPA and Risk Management
- Design Change Risk Management
- Process Change Risk Management
- Summary and Conclusion
- Implementing Risk Management Processes
- Combination Products and Risk Management
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Price INR* |
Savings |
Between Jan 14th and 20th |
14,000 |
2,000 |
Between Jan 21st and 27th |
15,000 |
1,000 |
Last Week |
16,000 |
0 |
* Price does not include taxes. 12.36% taxes will be included in final amount.
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10% discount on group of 5 or more.
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Cancellation Policy
Requests for cancellations or date transfers need to be received at least Seven (7) business days prior to the event in order to receive a 25% refund. If a cancellation or reschedule request is received less than Seven (7) business days before the start date, the penalty of 100% of the cost will be applied. Refunds will not be allowed for "no-shows". If your plans should change, you may designate a substitute to attend in your place at any time. This cancellation policy is strictly enforced.
Cancellation Liability
CO reserves the right to cancel events for any reason at anytime. Cancellation liability is limited to the return of payment ONLY. CO will not reimburse registrants for any travel cancellation fees or penalties, including airfare and hotel.
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