Month: August 2019

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

Management blogger

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

What jobs can a single family home property management New York company do

Management blogger

If you have single family and need to rent it out, but never planned on being a landlord, or had to relocate for a job, then a property management company can help you. They will have experience in the local rental market and assures you the best, saving you both time and money. They help you avoid costly mistakes, comply with complex legal requirements, and improve cash flow.

Single family home property management NY Company can do the following jobs for you: Comprehensive Marketing & Advertising Program:

Every day a property is vacant is money out of your pocket, and the cost of professional management quickly pays for itself in shorter vacancy times. The single home property NY Company spends thousands of dollars every month advertising our vacancies to get them filled-faster. Collections: Their rent collection processes are professional & tough, and they are extremely diligent in collecting your rent through a systematic, timely process. Reporting They will provide you with monthly accounting reports that include a balance sheet, income & expense statement, rent roll, rent ledger, expense and a copy of the bank statement. These reports are fully transparent, that also keeps you updated on all property activity, including vacancies, leasing, maintenance, inspections and financial reports. Routine Inspections They inspect your property on a regular basis both inside and out to assess condition and ensure tenant care and lease compliance.They also identify maintenance issues that can become costly if neglected. Maintenance Maintenance is can be one of the most difficult parts for you, if you manage your property. The single family home property management company will have 24/7 maintenance staff to do the job, who ensures you that the repairs are done in professional manner. Complete eviction and possession services In this economy, even with careful placement you may find yourself evicting a tenant. The property management company is extremely knowledgeable in state and local landlord and tenant laws. If rents are not paid on time, they initiate the legal steps necessary in the fastest possible time frame to minimize your costs and get the property leased again as soon as possible.

These property management companies have vast knowledge in the area and they know how complicated-and costly-managing property can be if not done carefully and professionally. So, hire an experienced property management company to save your money and time with a better process. Single family home property management NY For the best in real estate property management, Westchester and White Plains NY residents can turn to Real Property Management1 Westchester.They have local knowledge and experience in property management in Westchester and the greater White Plains NY area along with the property systems management, advertising and marketing capabilities. Real Property Management Westchester is able to bring to their clients simply the finest in service and results in terms of property management companies.

1. Real Property Management: Real Property Management is the nation’s local property manager. They provide both single & multi-family homes management services in New York and much more. Office is located at 777 Westchester Avenue, Suite 101, White Plains, NY 10604. You can call at (914) 288-6023 and fax at (866) 314-9739. You can send mail at . For more details, visit www.westchester.realpropertymgt.com

Ballast Water Control and Management Regulations

Management blogger

Water is commonly used as ballast for vessels that range from smaller sailboats to large tankers, cruise ships and other vessels. In both larger and smaller vessels, ballasts using water are designed to improve the stability of the vessel. Furthermore, the amount of water ballast can be adjusted as needed based on the weight of the vessel and the need for buoyancy and stability. Increasing water ballast generally requires the vessel to take on water from the area where it is located at the time, and decreasing water ballast discharges water from the vessel into the environment to decrease buoyancy. There are ballast water control and management regulations in place in many areas of the world that are designed to minimize the environmental impact associated with this process.

The Potential Issues There are a number of environmental issues that are related to the use of water ballast. Water that is taken into a vessel in one location may contain a number of biological elements that are native to that area, and these can include everything from microorganisms and pathogens to vegetation and animals. These biological elements are picked up by the vessel, transported to another area and discharged into a unique and foreign environment. The introduction of these non-native biological elements can be destructive in a number of ways. It can affect fragile ecosystems, spread pollution and illness and more. Ballast water control and management regulations are in place to minimize the impact of these potential issues related to water ballast.

Unique Regulations Around the Globe It is important to note that the regulations regarding ballast water vary from country to country. When navigating into unfamiliar waters, it is imperative to explore the local regulations in greater detail. Even regulations between neighboring countries like Canada, the United States and Mexico can vary significantly in certain areas.

Common Regulations Regarding Ballast Water While the regulations around the globe regarding ballast water may vary, many of the underlying principles regarding the regulations may be very similar. This is due in large part to the fact that the regulations largely are designed with the same environmental protection purposes in mind. Common regulations regarding ballast water relate to avoiding taking on water that is in known environmental protection areas or known polluted areas. For example, a marine sanctuary may be a protected environment while an area with visible algae growth may be a contaminated area. Water generally should not be taken on for ballast purposes close to sewage areas, dredging areas and other related areas where contamination or pollution may be more likely. In addition, it may be advised or regulated that ballast tanks be cleaned on a regular basis, and the amount of water discharged close to the coast may be regulated.

These are just a few of the common ballast water management regulations that may be in place in many coastal waters around the globe. It is important for anyone who is navigating a vessel to become familiar with ballast water regulations before entering a new area by sea.

IT Project Management Whats Coming in 2013 and Beyond

Management blogger

What got you here wont get you there. Its a simple, catchy line that over the past several years has become part of our business lexicon. The phrase was popularized by Marshall Goldsmiths best-selling book of the same title in 2007 and it essentially means the skills and behaviors that you possess today may prevent you from being more successful tomorrow.

Nowadays you hear the phrase used often in many contexts: sports, business, politics, and international affairs. And for project managers, especially IT project managers, Goldsmiths axiom is especially true. It wasnt so long ago that a PMI certification and expertise in waterfall project management made you a hot commodity in the job market.

But the times are changing. And considering several of the current trends in IT project management, what got you here in 2012 may not get you far in 2013 and beyond.

Agile Evolution

Since its introduction in 2001, the Agile development framework has seen incredible growth in popularity. Agiles flexible, iterative approach has gained steady approval in the marketplace as a more collaborative, real-time methodology than the more traditional waterfall model (for more on software development methodologies read our recent series on the topic).

What many industry insiders are now seeing, however, is that as Agiles use becomes more widespread, some organizations are favoring a hybrid approach that encompasses aspects of Agile as well as their own traditional methodologies. This may be a more practical approach for IT departments who may not be ready to make a big leap into Agile.

In a recent article, Jon Arnold of Centresource Interactive Agency explains his companys blend of traditional waterfall and Agile methodologies. The standard waterfall approachs main drawback, Arnold writes, is that youre never truly done with each phase. Despite the best laid plans, reality always sets in: a design decision needs to be amended to fit within a development environment; a forgotten interior page element suddenly becomes a necessity; or a developer needs a consult with a designer to work out an animation or visual transition.

Arnold says his teams love the iterative approach of Agile for development-intensive projects, but some clients can be a bit intimidated by what can be viewed as a frenetic, stressful schedule (though I suspect Agile purists might refer to this as cost-effective delivery). By combining some of the traditional planning and communication aspects of traditional waterfall with an Agile approach to development, Arnold has found a hybrid approach that works for many clients, and some industry watchers believe this best-of-breed approach may become more common in the future.

Show Me the Money (And Not Just the Cost Savings)

As more organizations take a portfolio management approach to their projects, the pressure to rationalize project investments via quantifiable business results will continue to increase. In todays tough economic climate, PMO heads face higher scrutiny than ever from organizational stakeholders, and more and more PMO heads are seen as portfolio managers, ensuring that projects meet or exceed a broad range of business metrics.

Cost savings, increased employee productivity, and higher application availability are just a few of the ways that PMOs have traditionally measured IT projects success (or lack thereof). For the most part these metrics are reflect a cost-based criteria for project justification (by lowering existing costs or avoiding costly failures and inefficiencies). And in a larger sense, the cost argument underwrites the organizational justification for the PMO itself. In other words, PMOs exist first and foremost to help an organization run more efficiently, not necessarily contribute directly to the bottom line.

Theres a growing point of view, however, that PMOs should make the leap from cost center to profit center. Simply said, a PMO must justify its existence and its collective project portfolio by directly contributing the organizations bottom line. While this may not sound revolutionary on the surface, it represents a fundamental shift from a passive PMO that prioritizes and implements projects as directed from organizational leaders to an active PMO that identifies and sells projects to internal stakeholders, emphasizing projects that materially impact business results. The PMO becomes, in effect, an internal, self-funded consulting organization. And within this new PMO paradigm the impact on project metrics is clearthe days of measuring project success based solely on a cost-based approach may be over.

PMP Certification, Not What It Used To Be (But Still Worth Having)

Over 470,000 people have earned the Project Management Professional (PMP) certification, and it remains easily the most well-known and valuable credential in the project management profession. But in a recent article discussing major industry trends, UK-based project management training firm ESI claims, Internal certifications in corporations and federal agencies will eclipse the PMP. This is quite a bold prediction.

And this may prompt some to ask if a PMP certification is worth having.The answer is (even if ESI turns out to be 100% correct) almost certainly yes. Even while many Fortune 500 companies and government agencies may have their own internal, proprietary credentials that are undoubtedly important inside the organization, those credentials lose much if not all their relevancy (and market value) once an individual leaves the company. Will the IT department at Ford care if youre a certified Bank of America project manager? Its hard to say, but theres little doubt the folks at Ford would fail to recognize the value of someone with a PMP credential.

The significance of ESIs prediction isnt necessarily what it says about the relative value of a PMP credential. What we should take away from the statement is that the skills and certifications organizations value can and will change over time. And for project managers, this underscores the importance of keeping current with their organizations and, in a larger sense, the marketplaces requirements.

The Future Is Change

For IT project managers the adage what got you here wont get you there seems especially apt. The profession continues to evolve, not only in terms of the skills needed to be successful, but also in light of a market place with an ever-increasing bottom line emphasis.

So what other factors or trends do you think will shape the future of project management? Id love to hear from you.

Visitor Management System Installation Operation Maintenance

Management blogger

Gone are the days of primitive visitor management! Electronic devices for visitor management are the need of the day. Areas with a large number of visitors adopt visitor management system to keep a track of the people checking in and out of the building. Schools use the system to prevent crime against children. Highly secured government offices install this device to control unauthorized access to sensitive data. Prison authorities are also resorting to the utilization of biometric visitor management solution. Friends and relatives who come to visit the inmates can be easily monitored with this tool. Its demand is increasing day-by-day, as more and more institutions opt for a programmed visitor management system.

Visitor management system, a computer based application, manages a large number of visitors in an arena. Modern systems are advanced and technology-driven mechanics. It functions in combination with a high resolution web camera. It offers the facility to check appointments, increase the pace of security screening at multiple access points and determine the time spent by the visitor inside the premises. Installation, operation and maintenance of a biometric visitor management solution may worry the user to some extent.

Merely purchasing a visitor management system does not serve your purpose. It needs to be properly installed. Minimum hardware and software requirements need to be met as specified by the provider. LAN connectivity is a must at the site of installation. Visitor management software can be downloaded. However, the user needs to have an average technical know-how in order to install it. Software needs to be installed in the unit and a web camera needs to be connected to it. People not having a hold on technical matters usually go for biometric visitor management solution providers. Providers study the site and the access points. They carry out the necessary task for installation, letting the end user relax!

Visitor management system is usually used in places where a large number of visitors come and go. It becomes difficult to keep a track of all the visitants by few employees. Biometric visitor management solutions generate a Photo ID of the first-time visitors in softcopy format. This is stored in the database to maintain records of all the people who visited the building. Some companies print the Photo ID for one-time or continuing use to speed the security screening process. Modern visitor management systems enable the operator to know the total visitors inside the premises. It also provides the facility of restricting troublesome visitors by sounding an alarm at the time of their visit. It can be combined with an access control for greater safety.

Biometric visitor management solution providers let the users buy an annual maintenance contract. They provide support at the time of any damage or malfunction. UPS for uninterrupted power supply is advisable to prevent any injure to the application. Visitor management systems require all the care and attention like other software! It should be protected from virus, worms and Trojan horses. Hacking of a visitor management system’s database may have serious consequences. Maintaining a visitor management system calls for extra attention.