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Tip of The Week – How You Can Be The Best Recall Specialist

April 26th, 2017 Posted by 21 CFR Part 11, ISO 13485, Recall, Services, Tip Of The Week 0 thoughts on “Tip of The Week – How You Can Be The Best Recall Specialist”

Recall Specialist – Medical Devices

Author: Rami Azulay (ALM/Medical Specialist at ORCANOS)

Are you eager  to join an innovative organisation? Do you want to play an integral role   helping clinicians improve  healthcare outcomes for patients? Have you always wanted to join a driven, entrepreneurial organisation that promotes from within? Then your ideal role is that of a Recall Specialist!

As a Recall Specialist, you will be required to provide Product Field Action, which means you will given direct access to all product design documents and verification, and validation protocols in order to perform effective  investigations. You will need access to both production and  manufacturing evidence documents on the device performance during production and  methods which support  the QC process. You will need access to the reporting entity so as to be able  to collect missing information needed to execute your CAPA process and of course, access to the support groups on Tier 1, 2, 3 and 4. These tiers support and manage a diverse range of medical devices. These tasks are only able to be carried out  through a collaborative working environment; not just in the human resource level, but also between the tools and repositories that hold that information.

The key duties of the recall specialist include: The regular reporting, follow-up and processing of regulatory actions, which require more time outside of your day to day tasks. While tools such as ORCANOS | MEDICAL system can provide you with proactive notifications based on Artificial Intelligence (AI) built into the system that compare your execution activity with the regulation and compliance to your organization standard operational procedure (SOP).  This will involve actioning on all aspects of Product Hold (PH) and Product Field Actions (PFA), and enacting the Universal Recall Procedure (Post Market Surveillance) to ensure the appropriate maintenance or removal of nonconforming products from the marketplace. Again ORCANOS | MEDICAL includes with the same system a Post Market Surveillance system call ORCANOS | SERVICE CENTER which act as gateway between the market to the manufacture or the distributor. It allows secured data communication between all parties, of course the AI system will cover regular reporting and follow up on actions, on that same system as well.

It is preferred that the Recall Specialist hold a tertiary science/engineering degree or equivalent. Such academic knowledge coupled with access to relevant and accurate information adds to the effectiveness of the Recall Specialist. ORCANOS Cloud based system, which is validated and 21 CRF Part 11 compliant, makes the world a much smaller place. Information that is needed is easily accessible  from anywhere – either from the event area (if you need to travel for investigation), or from your office where you communicate with other professionals, and information needs to be  secured as you work on  a quality event.

Having a single tool that can manage  all these activities R&D->Quality->Manufacturing->Support in one place, reduces lessens the learning curve for the recall specialist who has to be acquainted with multiple systems, reduces the cost of licensing which   enables access to  secured information needed to work efficiently. .

This role provides an exciting opportunity acting in the center of all things, using advanced tools and methods that can guide and protect the organization interest which will follow by constant recognition for creating a positive workplace environment. If you are looking to take your career within QA and post market to the next level this could a sure way to go.

QPack Bootcamp course for Admin/User to advantage your Organization

April 26th, 2015 Posted by Services, Workshops 0 thoughts on “QPack Bootcamp course for Admin/User to advantage your Organization”

QPack opens the power of Project Management, whether you’re a prepared nimble master, or simply a beginner.

 

Making and evaluating requirements, tasks stories during your development cycle, assembling a sprint excess, distinguishing group responsibility and speed, planning group action, reporting about group advancement are every crucial part of dexterous arranging yet now and again can appear like more work than really running the undertaking.

 

QPack is a tracker for groups arranging and building extraordinary work items such as storyboards or just developer task. The system meets expectations by associating group members, tools and measurements along these lines empowering them to work more efficiently.Teams pick QPack to catch and sort out issues, relegate work, and take after group movement. The application is accessible at your native work area additionally with their new portable interface on the Web and Mobile, you can get to QPack on the go. Workshop

 

The thought behind the product is taking into account the reason that errands are regularly sneaking in reports or covered in your inbox. Utilizing QPack revolutionists this, sorting out a groups errands and issues, appointing who is doing what and when it needs to be done, and following when its finished.

Orcanos Education Center, in exclusive agenda is conducting two upcoming courses:

QPack Admin Bootcamp

This QPack Administrator training project on orcanos evaluation server was built with an eye on the particular needs as highlighted by customers amid Orcanos arrangement consultancy ventures. Since the QPack administrator instructional training is taking into account real needs, you’ll be sure to know the information that the evaluation server contains to  a great degree applicable to the business you are participating in.

Taking into account genuine QPack admin training, based on 100’s cases and customer needs, preparing prerequisites, planned and conveyed by Orcanos Experts training personal, this immersive QPack Admin Training course will supply students with the obliged aptitudes to be Orcanos QPack system Administrator.

Who Should Attend:

The instructional class is gone for users how should install, upgrade, introduce, redesign, design or administrate QPack as a major aspect of their part. The QPack Admin Training course accept applicants who are acquainted with QPack.

Content:

QPack Admin course is broken down into 8 distinct modules with each one logically flowing into the next.

  • Module 1: Introduction to QPack Administration

  • Module 2: Installing & Upgrading QPack

  • Module 3: QPack Work Items Types

  • Module 4: QPack Web/Desktop Workflows

  • Module 5: QPack Notifications

  • Module 6: QPack Security

  • Module 7: QPack Maintenance

  • Module 8: QPack Add-ons & Plugins

 

QPack Admin Bootcamp is an immersive, functional substantial 2 day course, which happens every month at Orcanos offices (WebInar as well), from 9.30am to 5.30pm. Complimentary lunch and morning/evening refreshments are incorporated. To book your spot, contact sales@orcanos.com

 

QPack User Bootcamp

This QPack training program was built from the beginning to address the issues of SMB organizations that actualize Orcanos products and specifically QPack. The educational program was distinguished through our onsite consultancy work where customers highlighted real QPack preparing necessities.

Based on best practice, customer lessons learned. QPack training prerequisites requirements, planned and conveyed by Orcanos Expert professionals, were put into this immersive QPack User Bootcamp course and will supply users with the obliged abilities to adequately do their Orcanos QPack obligations.

Who Should Attend:

The QPack User Bootcamp instructional class is gone for candidates with little or no QPack experience that work in a position where QPack is a piece of their work process. The instructional class starts with some QPack essentials before proceeding onward to pragmatic assignments where the competitor will learn as they utilize QPack in some certifiable cases.

Content:

The QPack instructional class is separated into 9 particular modules with every one consistently streaming into the following.

  • Module 1: Introduction to QPack

  • Module 2: Project Management

  • Module 3: Work Item Operations 1

  • Module 3: Work Item Operations 2

  • Module 5: Workflows

  • Module 6: Dashboards

  • Module 7: Reporting

  • Module 8: Filtering

  • Module 9: Advanced Searching in QPack

QPack User Bootcamp is an immersive, practical heavy 1 day course, which takes place on Every Month, from 9.30am to 5.30pm. Complimentary lunch and morning/afternoon refreshments are included.

Book your place at this event for the special price of just $445

Membership means more than saving on events. You can also network with like-minded professionals, and gain recognition of your experience and expertise.

Orcanos Integrates QPack Instant Messaging Platform into QPack ALM System

June 26th, 2014 Posted by ALM 2.0, Company News, Services 0 thoughts on “Orcanos Integrates QPack Instant Messaging Platform into QPack ALM System”

TEL AVIV –(Business Wire)–Today Orcanos Ltd., developer of QPack ALM, the ALM medical system used by professional teams and companies worldwide, has released QPack messaging platform QPack.

This new capability unifies the communication of disparate teams and results in easier communication with automatic recording of all decisions, and customer interactions

QPack Instant messaging is designed to improve team performance by directly addressing its most important driver – team communication, as recent Researches shows that 50% of team performance improvement is attributable to the mode of communication. QPack Chat allows faster communication, combined with email notifications, and online invitation. QPack Chat contains the essential features needed, from group conferencing to shared work items, task management and custoemr complaints.

“Our vision has always been improving team communications along with professional toolsQPack instant messaging is a good example of our focus to drive business value to our customers,” said Zohar Peretz, CEO of Orcanos.

Pricing

The QPack Chat is free to use for all users to access for an unlimited time

About Orcanos

Orcanos Ltd.. is the developer of QPack ALM and the QPack Chat, the conversation platform used by thousands of companies to plan, share and organize work. The result of more than 20 years of research and development in the area of real-time communication, QPack Chat is built with text and chat at its core and includes file sharing, collaborative task management, shared calendars, automatic version control, all integrated into each conversation stream, saving time and providing context for faster, better decisions. QPack ALM is designed to support teams of all sizes and flexible for working with large amounts of raw data in fast-paced environments. Be it application development teams, marketing teams or teams spread across continents, QPack Chat is the conversation platform that improves business while organizing it all for you.

Orcanos

Contact

8 Tozeret Ha'aretz Street
Tel Aviv, Israel
+972-3-5372561
info@orcanos.com

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