Sunday, 5 May 2013

Medical Devices by Online Compliance Panel



Medical devices are products/devices used by a medical practitioner for diagnosis, surgery or any other type of therapy to cure patients (human or animal). According to Food and Drug Administration (FDA), Medical devices are classified within approximately 1,700 different types and can be broadly summarized within a total of 16 specialties which are described as panels. In order to assure the safety and efficiency of medical devices FDA has assigned three categories. These three classifications are defined by control limits of medical devices, which are, Class I General Controls, Class II General Controls and Special Controls and Class III General Controls and Premarket Approval.  These classifications are based on the intended use of medical devices as well as on their usage indications.

Medical industry today is expanding at a rapid pace and producing enormous opportunities and businesses throughout globe. New technologies and new benchmarks are set almost every day. Manufacturers are adopting sophisticated technologies and using best level of engineering for designing and mass production of these medical devices. Be it a temperature monitoring thermometer or robotics used for complicated heart surgeries. Best strategies and marketing practices are used in positioning these highly evolved medical devices. Innovative technologies and engineering are being used for mass production of such medical devices. Thus have transformed medical field as one of the most demanding industry in the market. 

Due to these increased demands and complexity involved in medical devices it has become essential to maintain a classified system which can ensure regulatory practice in this field. Thus the importance of regulatory practices is essential in order to maintain quality standards in medical devices. FDA has set up a separate department under the name Center for Devices and Radiological Health (CDRH) whose responsibility is to not only to monitor the firms who are involved in manufacturing and packaging the medical devices but also monitors radiation emitting medical devices like x-rays, ultrasound, MRIs, etc.

Medical devices regulatory requirements are broadly followed for Establishment registration, Medical Device Listing, Premarket Notification or Approval, Investigational Device Exemption for clinical studies, Quality System regulation, Labeling requirements and Medical Device Reporting.

These FDA medical device compliance and regulatory practices are only to promote and protect the public health. These practices are enforces through different acts regulator by FDA just to ensure the safety and effectiveness of these devices. Thus these compliance are must and has to be followed by each manufacturer or produces to attain a level or quality standards and maintain their FDA compliance stature.

Thursday, 28 March 2013

Nursing Management

It involves processes that are common to management such as planning, staffing, organizing, staffing, directing and controlling. Registered nurses with Master of Science in Nursing or Doctor of Nursing Practice can develop in leadership roles within the faculty of nursing. This is primarily because management positions necessitate candidates to hold advanced degrees in nursing. The important roles in nursing management include that of Director of Nursing in the lead followed by nurse manager and charge nurse. A Director of Nursing is a registered nurse responsible for supervising the care of every patient at a healthcare facility. This is senior nursing management position in an organization and reports to COO or CEO directly. It is also known with several fancy titles such as Chief Nursing Executive, Chief Nursing Officer or Vice-President of Nursing. Another category within this role is that of a service director. A service director oversees a particular service within the regulatory compliance training system. A nurse manager is the nurse who has management responsibilities of a nursing unit. They report to a service director. Their primary responsibilities include staffing, budgeting and routine operations of the unit. The charge nurse is assigned for a shift and accountable for the immediate functioning of the unit. This role is expected to ensure that nursing care is delivered safely and all patients receive adequate care online compliance training. They form the frontline management and in some cases, charge nurses are permanent members of the nursing management team. Then they are called shift supervisors. A female charge nurse is called a nursing sister or plain sister.

Thursday, 21 February 2013

The Hitchhiker's Guide to 483s and Warning Letters

Description:
Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain.
Audits by the FDA are perhaps the most intimidating of all events at a regulated facility. Each year, the FDA conducts several thousand audits, approximately half of which lead to findings that result in Form 483s. Most Form 483 audits are amicably resolved, but a few lead to serious consequences for the audited parties, starting with Warning Letters and ending with heavy fines and jail time for a few. This webinar, will assist you in responding to a 483 or Warning Letter so the consequences of the findings do not escalate beyond the current status.

Objectives of the Presentation:
  • FDA Inspections - background
  • Causes of Form 483 / Warning Letter
  • Some recent results of companies failing to respond appropriately
  • Best Practices for Responding to 483
  • Best Practices for Responding to Warning Letter
  • What to do if the responses fail
Who can Benefit:
Live Session - How it works
  • We will send Username and password 24 hours prior to webinar at your email address.
  • Webinar presentation handouts will be shared in pdf format, a day before live presentation.
  • Use the login details to participate in sessions.
  • Clear out your queries through interactive Q&A chat boxes with the speaker.
  • We need to know your experience, so please don't skip to provide us with your overall presentation feedback.
  • Get certification of attendance.
Recorded Session - How it works
  • Once you purchase a webinar you will receive username and password at your email address.
  • Use the login details to view recorded webinars.
  • Presentation handouts will also be shared in pdf format.
  • Access to the recording is valid only till 6 months starting from the date of purchase.
  • Get certification of attendance.

Project Management for Computer Systems Validation

Description:
Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company’s product.
Agenda
  • Project Management Basics
  • 21 CFR 11 and Computer Systems Validation (CSV)
  • The Project Charter
  • CSV Deliverables
  • Hiddent CSV Deliverables
  • Metrics & Gantt Charts
  • The 10 Deadly Sins!!
  • Q&A
Why Should you Attend:
Per the CDRH, 20% of product recalls in the medical device industry are due to faulty software!!! Yet, these human, financial and reputation capital expensive issues, can be averted with computerized systems validation and 21 CFR 11 compliance.

The Project Manager for a Validated Computerized System, has to deliver on time and on budget, but with the added risk of having to meet regulatory compliance, often causing project overruns, regulatory findings and missed times to market. This class will explain the basic tenets of project management, the basic tenets of 21 CFR 11 compliance for Computer Systems Validation and will show how to marry the two, to deliver on time and on budget while meeting regulatory compliance requirements.

Objectives of the Presentation:
  • Basics of Project Management
  • Basics of Computer Systems Validation
  • Project Planning for a Computer Systems Validation Project
  • Common Pitfalls and How to Avoid them
Who can Benefit:
  • Project Managers
  • IT Management
  • Business Process Owners
  • Quality Managers
  • Quality Engineers
  • GxP
  • Consultants
Live Session - How it works
  • We will send Username and password 24 hours prior to webinar at your email address.
  • Webinar presentation handouts will be shared in pdf format, a day before live presentation.
  • Use the login details to participate in sessions.
  • Clear out your queries through interactive Q&A chat boxes with the speaker.
  • We need to know your experience, so please don't skip to provide us with your overall presentation feedback.
  • Get certification of attendance.
Recorded Session - How it works
  • Once you purchase a webinar you will receive username and password at your email address.
  • Use the login details to view recorded webinars.
  • Presentation handouts will also be shared in pdf format.
  • Access to the recording is valid only till 6 months starting from the date of purchase.
  • Get certification of attendance.