How to control those risks and monitor the effectiveness of the controls put in place

Overview of this session Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.

You’ll learn techniques that can help you identify hazards and potential harms. You’ll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products. A rigorous risk management process can prevent serious problems and costs for your company.

risk-management-definitionIn this webinar we’ll cover:

  • Overview and Definitions
  • FDA Expectations
  • ISO14971 Regulation
  • Linkages to Design Controls, Production Controls, Investigations, and CAPA
  • Risk Management throughout the product lifecycle
  • Common mistakes
  • Best Practices

Why should you have to Attend The cost of poor product risk management can be staggering. Complaints, Medical Device Reports, recalls, and serious adverse impact to your customers can all result from poor risk management. And these types of problems expose you to regulatory inspections and citations. Many companies have even experienced class action law suits because of product quality issues. An effective program of risk management can help you proactively identify and mitigate product risks. A good risk management process can help you methodically identify, mitigate, and monitor risk throughout the product life-cycle.

These are the areas covered by the speaker Susanne Manz

  • Overview of the ISO14971 standard as it applies to medical device companies
  • Integrating the new standard with ISO 13485 as part of your overall QMS
  • Conducting a review of the intended use of your device
  • Stages of Risk Management as well as Tools and Techniques
  • Identifying hazards in your product or production process, and estimating their severity
  • Judging the probability that harm may occur from those hazards
  • How to control those risks and monitor the effectiveness of the controls put in place

By login with this Risk Management Techniques for Medical Devices

Which are the experts benefited by this session are as shown in the below

Risk-Training

  • Design Engineer
  • Manufacturing Engineer
  • Quality Engineer
  • R&D Personnel
  • R&D Project Managers
  • Quality Managers
  • Auditors
  • Regulatory Affairs Specialist
  • R&D Manager

Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.

One of the technique described in ISO 14971 is Hazard Analysis

The confusing terms”hazard”, hazardous situation”,”harm”,”causative event”,”ALARP”,”risk index”,”residual risk” will be explained. We will go step by step through a template for hazard analysis so that the process is clear. Examples of hazards and hazardous situations will be discussed. How to deal with residual risk will be discussed. We will go step by step through a typical hazard analysis. We will explain how to integrate Human Factors studies into the Hazard Analysis and how to integrate Hazard Analysis into the design program.

Medical Devices

The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. FMEA and FTA consider only fault conditions and are more suited as reliability tools than as product safety tools. In this seminar we will explain in detail the process of conducting a hazard analysis.

Why should you have to attend,  FDA expects that as part of a product development program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Hazard Analysis is the most powerful of the risk management tools described in ISO 14971 but it is very confusing. Many new concepts are introduced. we will explain these concepts and provide examples so that the process is clear.

Process Hazard Analysis-1

Edwin Waldbusser can cover the areas in

  • Explanation of Hazard Analysis terms
  • Hazard Analysis Process Explanation using a Template
  • Examples of Terms will be given
  • Hazard Analysis Examples will be Covered Step by Step

Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

By login this Hazard Analysis Process you may know about the medical device hazard analysis.

Healthcare services that drives up the cost of the health benefit plan

Employers who sponsor self-funded health benefit plan programs have a difficulty in finding methods that are acceptable and compliant from the regulatory perspective. Covered individuals have to show high levels of cooperation if they have to adapt these benefit plan programs, because if cooperation is lacking among covered individuals; it leads to less than desirable and ineffective use of healthcare services.

This in turn raises the cost of the health benefit plan, making it burdensome for employers and failing to meet employee expectations. Many of the programs and incentives that employers have adopted have aimed at controlling health benefit plan use, so that the overall cost of offering health benefits can be reduced. However, many of these incentives have violated the privacy of covered individuals because they track health related activities and outcomes. This is viewed seriously by regulators.

This leaves employers confused about the kind of benefit plan programs that are compliant, because compliant programs are the only means to ensuring that the benefit plan programs serve their purpose and are also valid from the legal and regulatory perspectives.

Clearing the confusion

How do employers adapt such benefit plan programs? How do they wade through the muddle to clear the air about regulatory requirements for benefit plan programs? This is the teaching a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering.

The speaker of this valuable session is Jed Constantz, who is a healthcare professional from upstate New York with over 30 years of experience in the healthcare industry. He has served in a number of administrative and management positions for two upstate New York hospitals, a home health agency, several physician organizations, and a physician/hospital organization. To gain insights into how to adapt benefit plan programs that are useful and compliant from the regulatory perspective; please log on to Employees Health Benefit Plan to register.

At this session, which will be highly useful to professionals who deal with benefit plan programs, such as CEO’s, CFO’s, COO’s, VP HR/Benefits and Benefit Plan Brokers/Consultants; Jed will offer useful insights into regulatory compliant models and strategies that employers can leverage to elicit increased cooperation among covered individuals. He will also guide them on the appropriate incentive models that protect the privacy of those who choose to participate in these programs.

Helping employers get employee cooperation

Employers, naturally, look for strategies and concepts that drive high levels of cooperation among health plan covered individuals and are compliant with federal regulations concerning non-discrimination. They are often apprehensive about violating Protected Health Information (PHI) privacy rules and are uncertain about best practices for high level health plan participant cooperation. The speaker at this webinar will seek to clear their doubts about existing models and programs and help create high level health plan participant cooperation.

Jed will cover the following areas at this webinar:

o  Regulatory Compliant models for gaining and increasing covered individual cooperation with health benefit plan cost control initiatives

o  Aligning the interests of covered individuals with those of the employer sponsor of a self-funded benefit plan

o  Development of incentives for covered individuals that reward behaviors and completed activities that are compliant with Federal requirements and regulations.