day In-person seminar on Implementing Risk Management Principles and Activities within a Quality

Overview:

Risk management integrated into the overall quality management is one of the main components for global medical device compliance. To meet the approval requirements for almost every regulated market a comprehensive implementation and documentation of a full risk management lifecycle has to be demonstrated. This course introduces the major components necessary to achieve global regulatory compliance and approvability. The main emphasis is on European and US regulation. A practical path to implanting a successful risk management system across different subsystems will be presented. The main issues covered are risk management, compliance with IEC60601-1, usability engineering and software risk management. The course is based on 20+ years of experience in the medical device industry and emphasizes practical implementation issues and not just theoretical background. If your company is developing devices for international markets this seminar will give you the information needed to design and document a globally acceptable design lifecycle.

Why you should attend:

Since risk management is a wide spanning activity involving management, engineering, QA/RA, clinical affairs and manufacturing / sustaining engineering, the seminar addresses a broad audience and generates a common understanding of risk management principles and methods. Some elements of the agenda a specific to design engineering but a shared knowledge of risk management principles is essential to successfully implement a working risk management system.

Course Outline: Day 1 – Agenda Lecture 1: Introduction into Risk Management and Quality System Integration Why risk management? Risk Management Lifecycle and stakeholders Risk Management Benefits How I to implement Risk Management into ISO13486 Q&A

Lecture 2: Risk Management to ISO 14971:2012 Risk Management Planning Risk Management Life Cycle Hazard Identification

Day 2 – Agenda Lecture 3: IEC 60601-1 3rd edition (incl. A1) References to Risk Management Section 4 Risk Related Issues Compliance for Non-Software Related Issues The IEC TRF (technical report form)

Lecture 4: Usability Risk Management (IEC62304:2006 / FDA usability Guidance) Use errors as hazard source User intervention as hazard mitigation Usability engineering lifecycle Application specification

Lecture 5: Software Risk Management (IEC62304 / FDA software reviewers’ guidance): Critical Software Issues Software Hazard Mitigation Strategies Software Item, Unit and System Definition Software Failures as Hazard Sources

Who Will Benefit: This 2-day course is particularly relevant to managers, supervisors, QA / RA and design/system engineers. Even experienced personnel will benefit from the across industry perspective and the illustration of standard practices that only a presenter with extensive experience in more than 100 projects can provide. Specific positions that would benefit are: Project managers Risk managers Engineering management Quality Assurance personnel Regulatory and Compliance professionals responsible for FDA / notified body interactions System and design Engineers Software Engineers Usability Engineers Verification / validation personnel Production Managers ABOUT SPEAKER – Markus Weber Principal Consultant, System Safety Inc.

Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms.

Location: Singapore

27th & 28th February 2014

9:00AM-6:00PM Venue: Mandarin Orchard Singapore Address: 333 Orchard Road, Singapore 238867 Price: $1,595.00 Discount: Register now and save $200. (Early Bird) Until January 25, Early Bird Price: $1,595.00 from January 26 to February25, Regular Price: $1,795.00 Contact Information: Event Coordinator Call: +65-3158-3448 Fax: 302-288-6884 Email: Website: https://www.globalcompliancepanel.com LIVE CHAT SUPPORT – http://www.globalcompliancepanel.com/chat/client.php Event Link: http://bit.ly/1dcfswj NetZealous LLC, DBA GlobalCompliancePanel, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Phone: 1800 447 9407

Benefits Of Time Management

Each year, our society is having a great fast paced. And we are all looking for the ways to help us complete the things that we need to do in the possible shortest time so that we can add additional time to have for ourselves. This will lead us to get in trouble if we doing things fast that mistakes our made. If this case happened, this will tend us to spend additional time correcting our mistakes that can create a cruel cycle. There are times when we simply need to slow things down.

It is strange, to see how few of them really look deeply into the benefits of time management involving with so many businesses taking up and so many forceful cost cutting measures. Having an effective management of time is like something having an effective management of any other resources that can save your company a huge amount of money if it is properly implemented. With the huge cost of outsourcing and moving operations overseas, it seems like every measure should be taken at home to improve efficiency before such a drastic solution is proposed. Effective time management enables you to lead a more balanced life by helping you find the time and energy to devote to all the important areas of your life.

In order for us to become more organize, one of the best things that we can do is to help ourselves first. Organization can help us manage our time better. There are many benefits of time management. We can be more productive as well as more efficient. Effective time management increases your productivity allowing you to accomplish more with less effort. Improving your productivity is not about doing more in less time, it is really about accomplishing more by working less that we can save our money and time. This creates a happy employer and when this reflects back to you, it may mean additional compensation in money or time off.

Although the modern understanding of the benefits of time management is a little bit different than as it was originally planned, the concept still goes back about as far as Henry Ford and the invention of the assembly line. Of course, performance management is still nothing new. Different steps were taken to improve the program constantly, resulting in less work for the same product.

It is easy to see the benefits of time management on an assembly line. Time management benefits can little bit less obvious if you are in an office environment. This does not mean that they are not important! The benefits of time management will show up in the books, but it will take a while. After all, the tasks that people have are usually a little bit less concrete. Rather than manufacturing a car, you have to type up financial reports, communicate with clients, and do other similar business tasks.

All of us release the benefits of time management, but implementing the skills may be something new to us. And i try to have the list of work well for me. When I make lists at the beginning of each day I find I am more organize to get the things done that are needed. My daily routine everyday is to write down the things that i would like to as well as needed to accomplish for that day. Then i prioritize the list in order of what is the most important to accomplish. For example if I need to meet with a co-worker on a different floor and also deliver reports to another department I will do this at the same time. This way I am away from my desk for one period of time thus cutting down on the amount of running around I need to do. I also do as much correspondence at one time as possible to limit the number of trips to the printer, copier and mail room. Also I find when I am out and about away from my office I spend time greeting co-worker and doing other things that can eat away at my time. Some of these techniques may seem rigid, however the benefits of this time management pay off by getting things done and creating more time by the end of the week. Since I have been doing my work following these methods I find that I am often able to leave early at the end of the week.

The individual performance and the job satisfaction of any particular worker is the greatest benefits of time management. Our job duties increases and can seem so overwhelming without having an effective time management training. After all, when a worker is used to getting a certain amount accomplished in a single day, adding additional tasks on is never welcome. The benefits of time management training is that it allows you to provide a way to ease workers into taking on additional responsibilities. It will be able you to cope up if you provide with adequate training. If not, you can often lose some of your best, most seasoned employees to greener fields. No matter what employee benefits you offer, if you stress them out too much, or stretch their time too thin, they will leave for another company.

Reputation Management – The Key to your Brand Management

What makes for the transition of a simple name into a globally acclaimed Brand? It is your Brand’s Reputation. It is simple – if you want to make a good name in the market ensure that, you not only build it but also protect it. Reputation Management is a key concept today for major brands across the globe to increase awareness and customer satisfaction. The word Reputation Management itself says it all. Initially aimed at broadening public relations apart from media relations, the concept has undergone an immense change over the few decades thanks to the advancement in technology and the growing popularity of the Internet and Social Media. Today the focus has shifted more towards Site Reviews, Social Media and getting on the top search results in that particular brand category. By means of this article, let us have a closer look at the concept of Reputation Management and how it helps businesses today.

What is Reputation Management?

In simple terms, it means monitoring the reputation of a brand. It involves tackling negative content that can damage the reputation of a brand and analyzing customer feedback to understand the concerns with regards to a brand’s reputation. It is a process focused on creating a certain image in the public eye, by understanding people’s perception of the brand and ensuring that it stays in line with the company’s goals. The most common way that this is being accomplished is through Social Media. This includes the use of sites like Facebook, Twitter etc. to get people to follow the brand and publish positive reviews online. Customer reviews from e-commerce sites like E-bay, Amazon etc. are also helpful in building the brand’s reputation. The focus is to minimize negative feedback by addressing concerns detrimental to the brand’s reputation.

Where can I get help for Reputation Management?

There are many online Reputation Management service providers who can help you get this sorted. It is always better to get them do this for you instead of doing it yourself. With the right tools and expertise, a team of professionals can help protect and establish a positive image of your brand. These service providers will also be able to do all the research and analysis required for your brand image, which may not be possible for you to do on your own. Using a professional service ensures that you have that competitive edge over your competitors.

Is Reputation Management worth the Money?

The growing popularity of the Internet and Online Branding means that your online image is very crucial. Most people are sure to check your brand online before opting for your products and services. A search result that draws attention to negative feedback or an errant customer leaving a wrong review about your brand can spell disaster to your brand image. Apart from this, the growing competition around us has led many a brand to resort to unethical means to tarnish other brand images. Online public platforms, fake blogs and various other techniques are use to populate negative feedback and false information. Though legal action can be taken against such practices, rebuilding your online brand image will definitely take some time and more money. So why not nip these problems in the bud, as it were, and use Reputation Management services to emerge on top.

Many believe that most of these things do not need expert help and can be done yourself. However, I say, you have only one chance to make a lasting impression on your customers. Why lose it because as it goes;

“First Impression is the Last Impression & and you do not get a second chance to make a first impression.”

About Author: – This article is written by Alex Smith, a professional content strategist for Easy Media Network. He provides content on social media marketing, search engine optimization and other internet marketing services for both domestic and international clients.

Making the paperless office a reality with document management systems

The paperless office or paperless office software is not a new business objective, the advertising slogan which suggested that after the advent of computers in the offices role would be unnecessary, was born in 1975, the year in which Business Week first coined this phrase in an article in which futuristic vision embodied in the office.
Unfortunately this goal has not yet been achieved, although some experience of large companies allowed to be optimistic.

It is why the adaptation of a policy to the paperless office must be born with the premise that the most important change is in the minds of its employees, and not in their information systems.
In fact, the technologies allow information management ever closer to the idea of the paperless office. And this advance in document management technology the new factor that allows IT departments to achieve success and meet the challenge of implementing a paperless office.
After years of development, document management systems have finally managed to cover the entire life cycle of the document in the company, from management or ingestion of input documents to the system, to the record management or management of historical records and all intermediate processes, covering all complex business flows requires an organization today.

Input Management:
Historically one of the weaknesses of the corporate document management has been the source of documentation. Often the process of approaching a paperless office failed by the mere fact that it was very powerful document management system selected, the documents were originally generated in digital format and no- cost time / money for digitization consistent information was a barrier (sometimes insurmountable ) to achieve the complete elimination of paper in business processes.
Today intake systems, documentation or allow the introduction of management input from various sources Fax, mail , papers, manuscripts, etc. mass scanners . Documentation in various formats that is automatically recognized , stored , cataloged and redirected to systems management business logic ( usually a Document Management System ), removing in the process the critical information required.

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