Verification vs. Validation – Product Process Software and QMS 2018

Verification vs. Validation – Product Process Software and QMS 2018
Event on 2018-01-22 09:00:00
Course "Verification vs. Validation – Product Process Software and QMS" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions. Why you should attend: This session helps participants: Understand Verification and Validation, differences and how they work together;Discuss recent regulatory expectations;Know how to document a "risk-based" rationale, and use it in a resource-constrained environment;Determine key "milestones" and "tasks" in a project;Locate and document key subject "inputs";Compile "generic" Master and Individual Validation Plans;Learn the key element of a Product V&V File/Protocol;Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols;Get a grasp of basic Test Case construction;Understand sample sizes and their justification;Learn the key elements of Software V&V expected by the FDA and how to document;Deal with hardware and software vendors, sales and marketingConsider a field-tested software V&V documentation "model";See how to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR Part 11. Who will benefit: This workshop will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and V&V activities / plan(s). This information addresses Medical Devices, Pharmaceutical, Diagnostic, and Biologics requirements and implementation. The employees who will benefit include: Senior and middle management and staffRegulatory AffairsQuality Assurance or Quality Control ProfessionalsQA/QCIT/ISR&DProduction ManagementManufacturing EngineersProcess EngineersSoftware EngineersProject ManagersHardware and software vendors, sales and marketingAny professional tasked with V&V responsibilities Agenda: Day 1 Schedule Lecture 1: Master Validation Planning and the Master Validation Plan(s) Lecture 2: Product, Process / Equipment Hardware V&V Lecture 3: Product / Device V&V Lecture 4: Software V&V Lecture 5: Quality Management System / 21 CFR Part 11 V&V Lecture 6: Summary of morning discussion Lecture 7: Group activity on the MVPs Lecture 8: Review of group activity and Q&A Day 2 Schedule Lecture 1: Software V&V documentation "model" Lecture 2: Software V&V protocols – "black box", "white box" Lecture 3: Electronic Records and Electronic Signatures (Part 11) Lecture 4: Summary of morning discussion Lecture 5: Group activity on 1) hardware / equipment, and 2) software V&V protocols Lecture 6: Review of group activity and Q&A Lecture 7: Course summary discussion Lecture 8: Summary of morning discussion Lecture 9: Group activity on the MVPs Lecture 10: Review of group activity and Q&A Speaker John E Lincoln Consultant, Medical device and Regulatory affairs, John E Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company. John, a graduate of UCLA, is a medical device and Regulatory Affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management and U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles and workshops worldwide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions and risk management per ISO 14971 and implemented projects. With over 28 years of experience in the FDA-regulated medical products industry, he has worked from start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, and Tyco/Mallinckrodt. Location: St. George UT Date: January 22nd & 23rd, 2018 and Time: 9:00 AM to 6:00 PM Venue: Hilton Garden Inn St. George 1731 South Convention Center Drive, Saint George, Utah, 84790, USA Price: Price: ,295.00 (Seminar Fee for One Delegate) Register now and save 0. (Early Bird) Until January 01, Early Bird Price: ,295.00 From December 31 to January 20, Regular Price: ,495.00 Register for 5 attendees Price: ,885.00 ,475.00 You Save: ,590.00 (40%)* Register for 10 attendees Price: ,122.00 ,950.00 You Save: ,828.00 (45%)* Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry. As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants. For More Information- https://www.globalcompliancepanel.com/control/sponsorship Contact us today! NetZealous LLC DBA GlobalCompliancePanel john.robinson@globalcompliancepanel.com support@globalcompliancepanel.com Toll free: +1-800-447-9407 Phone: +1-510-584-9661 Website: http://www.globalcompliancepanel.com Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901450SEMINAR?ticketleap-January-2018-SEO Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/ Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/ Follow us on Twitter: https://twitter.com/GCPanel Seminar Fee for One Delegate – 95.00

at The Hilton Garden Inn
1731S.ConventionCenterDrive
Saint George, United States

Documenting Software for FDA Submissions 2017

Documenting Software for FDA Submissions 2017
Event on 2017-08-10 09:00:00
Course "Documenting Software for FDA Submissions" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304. In fact, those principles – have clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution – actually augment rather than contradict the Agile manifesto.
The Agile approach helps companies avoid hearing bad news late in a project, by delivering incrementally, integrating regularly, and leaving room for learning as the user stories are refined. In addition, it provides real information on progress and project speed to stakeholders outside the development group.
Documentation under Agile, then, can take advantage of iterative development. Each objection to Agile reveals another point of discipline for effective Agile teams. Requirements can be captured as they are elaborated, and test cases can be firmed up as they are generated during development. For these pieces to fit together, quality processes need to be flexible.
Even clearer is the case for hazard analysis – it and Agile are made for each other. Just as requirements are refined in the course of a project, so too does the knowledge of hazards and design of their mitigations. Risk management, therefore, can and should be included in iteration tasks.
We are coming to see that Agile methods not only result in acceptable medical device development, but lead to much better outcomes. IEC 62304 does not specify any lifecycle model (and states as much); documentation can therefore grow out of iterative activities.

Why you should attend:

Agile methods are appearing more and more in regulated health-related applications. The teams carrying out this development must work both rapidly and flexibly, since they are obligated to satisfy not only their business management, but also the patients and caregivers, and, of course, the regulatory bodies who must approve their products. Teams must document all aspects of their development – requirements, design, tests, hazard analysis, usability, and traceability. How do we achieve all that and remain Agile?
Many companies struggle with meeting all these expectations; software-related product recalls and failed companies are the legacy of traditional, sequential methods.
How can we gather these as development proceeds, while minimizing overhead? How can we assure that inputs are reviewed and approved, without getting mired in the document signoff spiral? How can we address design reviews without bogging down the team in long, droning meetings? How can we capture traceability as a natural outcome of our work?
Experience is showing, and the AAMI Agile report (TIR 45) has stated, that when Agile is properly applied in the context of a quality system and robust safety risk management, its emphasis on nimbleness and ongoing learning can be reconciled with regulatory expectations of well-documented development.

Areas Covered in the Session:

• Agile vs IEC 62304: an apparent contradiction?
• The role and value of documentation
• The REAL regulatory requirements
• Specific documents required for an FDA submission
• Areas where most development processes bog down
• Iteration – well suited for risk, usability, and design reviews
• Key practices to bridge the Agile and regulated worlds
• Agile is not only acceptable for medical device software, but can be clearly superior

Who Will Benefit:

• Regulatory Specialists
• Quality Assurance Specialists
• Documentation Specialists
• Test Managers
• Software Team Leaders and Lead Developers
• Project and Program Managers

Agenda:

Day 1 Schedule

Lecture 1:
Are Agile and medical device standards contradictory?
Lecture 2:
What is the value of documentation?
Lecture 3:
What do the regulatory bodies require?
Lecture 4:
Consider the software documentation required for an FDA submission

Day 2 Schedule

Lecture 1:
Where do most companies get bogged down?
Lecture 2:
Iteration works well for risk, usability and design reviews
Lecture 3:
Practices are the bridge
Lecture 4:
The core values align

Speaker
Brian Shoemaker

Brian Shoemaker consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures. He has conducted validation both on product software and on internal software, developed software quality systems, audited software quality processes (including agile methodology), and evaluated 21 CFR Part 11 compliance. He has had clients in clinical diagnostics, medical device engineering, medical imaging, medical-device fabrics manufacturing, contract lyophilization, clinical trial software, dental prosthetics, and bone-repair implants. He has worked with companies in Germany and Switzerland as well as the U.S.
Previous to founding ShoeBar Associates, Brian had quality roles at PPD Informatics, Doxis, Inc., and Behring Diagnostics, Inc. Brian earned his Ph.D. in chemistry from the University of Illinois; he has achieved the ASQ Software Quality Engineer certification.

Location: Washington, DC Date: August 10th & 11th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Courtyard Arlington Crystal City/Reagan National Airport 2899 Jefferson Davis Highway Arlington, VA 22202 USA

Price:

Register now and save 0. (Early Bird)
Price: ,295.00 (Seminar Fee for One Delegate)
Until June 30, Early Bird Price: ,295.00 From July 01 to August 08, Regular Price: ,495.00
Register for 5 attendees Price: ,885.00 ,475.00 You Save: ,590.00 (40%)*
Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar
At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901070SEMINAR?eventful-August-2017-SEO

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel

at Courtyard Arlington Crystal City/Reagan National Airport
2899 Jefferson Davis Highway Arlington, VA 22202 USA
Arlington, United States

Microsoft Will Bring Its SQL Database Software to Linux

Microsoft Will Bring Its SQL Database Software to Linux
For the past five years RedMonk has tracked the popularity of different programming languages by charting the number of questions about each language asked on the popular programming question-and-answer site StackOverflow and the number of lines of …
Read more on WIRED

Verizon's “Zombie Cookies” Will Finally Be Easier to Kill
The use of cookies for ad targeting is common, but Verizon took the practice a step further by inserting cookies into its all its customers' unencrypted Internet traffic, allowing it to learn how customers used mobile apps and websites outside of …
Read more on WIRED

Bill Guthrie Interviews Successful Entrepreneurs and Marketers, inspired by Tim Ferris, John Lee Dumas, Pat Flynn, Seth Godin, Michael Hyatt, about Online Business, Social Media, Software, Product Creation, Building a Business and Becoming an Entrepreneu – PeakMarketer | Daily Interviews with Today’s Top Marketers and Entrepreneurs


Bill Guthrie Interviews Successful Entrepreneurs and Marketers, inspired by Tim Ferris, John Lee Dumas, Pat Flynn, Seth Godin, Michael Hyatt, about Online Business, Social Media, Software, Product Creation, Building a Business and Becoming an Entrepreneu – PeakMarketer | Daily Interviews with Today’s Top Marketers and Entrepreneurs
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How to vet new software developers

How to vet new software developers
… can on the resume. Some of the most popular methods we have seen are listed below, though companies will often need to mix it up based on what role they are filling. … Sites like GapJumper can facilitate the process for the hiring company. This …
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Weeding out malvertising
It's difficult to spot, is often found lurking on even the most popular websites and is able to expose your personal information to criminals. Malvertising, which is the term for when malware is slipped into online advertisements, is displayed on web …
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Good Line boosts speed for popular websites
Russian regional ISP Good Line, working in the Kemerovo region, has expanded the list of websites accessible at up to 100 Mbps under the 'Accelerate' internet tariff. The higher speed is available for Facebook, Twitter, Vimeo, Instagram, Coub, Vine, …
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Popcorn Time Blocked: Downloaded Movie Software Still Works, But Italian Users

Popcorn Time Blocked: Downloaded Movie Software Still Works, But Italian Users
An Italian criminal court has ordered internet service providers to block access to three of the most popular Popcorn Time websites where users download the free movie streaming software. Popcorn-Time.se, PopcornTime.io and PopcornTimeItalia.com will …
Read more on International Business Times

Google's ad penalties are more significant than Apple's ad blocker
But Google's recent decision to start penalizing websites featuring app install ads –intrusive ad units that slow page load times and engulf the entire screen — might be a more significant way to improve the browsing experience. Now, there are some …
Read more on Gigaom

Medium's Evan Williams To Publishers: Your Website Is Toast
More than that, Williams thinks the key will be providing social context for content. Perhaps outside of huge traffic drivers such as Buzzfeed, he contends, most publishers can't make much money from running their own websites, especially with current …
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Vetter Software Announces Record Second Quarter

Today, Vetter Software, the leading cloud veterinary healthcare company, announced record results for the second quarter of 2015, highlighted by an increase in platform adoption of more than 100%, as compared to the first quarter of 2015, and integrations with Google and HelloFax.

A paradigm shift toward cloud technology is clearly underway in the veterinary healthcare industry, said Sagi Solomon, Founder and CEO of Vetter Software. Eight consecutive quarters of double-digit growth is a clear indication that clinics have accepted the cloud as their preferred technology platform for managing their businesses, and Vetter Software as their preferred technology provider. Our continuing, and accelerating, success remains firmly grounded in our commitment to delivering an exceptional customer experience from a service and technology perspective.

Highlights from Vetter Softwares second quarter include:

Grew clinic count by more than 15% quarter-over-quarter

Increased platform adoption, measured as the total number of patients managed, by more than 100% quarter-over-quarter

Released integration with Google Cloud Print and HelloFax, and added additional features to the industrys only cloud integration with MWI Veterinary Supply

Introduced numerous product innovations including employee time clock, support for video attachments, the ability to dynamically set pricing based on various cost measures and support for faxing documents

Continued its support of not-for-profit organizations by partnering with The Jacksonville Humane Society and Veterinarians International

About Vetter Software

Vetter Software is the leading cloud veterinary healthcare company. Our mission is to deliver innovation that helps coordinate and improve the care and health of the world’s animals. Vetter Software was founded in 2011 and is based in Santa Clara, California. To learn more about Vetter Software, please visit http://www.vettersoftware.com. Follow us on Twitter @vettersoftware and like us on Facebook at https://www.facebook.com/VetterSoftware.


Perth Software Company Anahata Announces Oracle MySQL as Strategic Database



Anahata Technologies Pty Ltd

Anahata, the software development company, specializes in assessment, planning and executing exceptional designs of tailor-made ICT applications software. The firm delivers applications that are inexpensive to acquire, easy maintain and cost-efficient in terms of generating revenue.

The MySQL technology is easy to configure, stable and secure with competent support from the open source Anahata coding community. Clients have the choice of getting maintenance from Oracle as well. The technology is easily incorporated with Anahatas Java development platform resulting in minimal fees. Clients are guaranteed of a relatively short return on investment due to features that include high availability, online backup and clustering. MySQL serves as a popular choice for software development and plays a central role in the popular LAMP open source web application software stack. Clients are able to benefit by gaining multi-user access to various databases.

Currently, Anahata employs such technologies to provide customized workplace optimization solutions in addition to advanced software applications that meet the needs and objectives of clients.

Anahata targets the attainment of quality throughout the method of software package development. It achieves this through the utilization of versatile practices and apparatuses. Customers square measure ready to superintend the event method whereas prioritizing goals and tasks.

The software developer employs open standards in using open source technology when delivering cross-platform solutions, making the applications more stable, compatible and secure. This results in a reduction of upfront and ongoing fees while ensuring durable software.

Anahata has years of experience in embedded device development in software development Perth using cross-platform technologies. The company supplies embedded software that runs on low resource devices like AMD, ARM and Intel processors. The devices are connected to outer sensors via USB, CAN and Ethernet. They can be in vehicles and machinery during mining activity.

The company concentrates on cross-platform independence and portability in its custom software development. As such, Anahatas ICT solutions are seamlessly integrated with platforms like Mac, Windows and Linux. Consequently, the company delivers solutions for Mac platforms that are easily incorporated into Mac applications. Anahata has developed the patients record management system on the Mac platform that runs perfectly alongside medical applications like Genie.

Anahata issues clients with a three month warranty and provides support during this period through unlimited consultation by email and telephone. These services are provided throughout the day and seven days a week. Clients are thus able to access the issue based and online task management system to report any errors or defects and make requests for enhancements. This is part of the customer-centric approach utilized by the company.

The Software Company has also collaborated with reputable software vendors in Perth to deliver integrated turnkey solutions. Such technologies include infrastructure, hosting, mobility, barcode printing as well as real time monitoring and tracking.

After the delivery of the customized software application, Anahata partners with its clients to market the software and promote the clients business operations. It provides business process outsourcing services via digital media in email marketing, search engine optimization and content writing, enabling clients to focus on core business activities. It gives clients the ability to save time and run a more efficient business operation at minimal cost.

About Anahata Technologies Pty Ltd

Founded in Western Australia in 2010 by Pablo Rodriguez Pina, Anahata Technologies Pty Ltd is an Australian privately owned software development company with presence in Perth and Melbourne specializing in the analysis, design, implementation and support of cost-effective, custom built software applications.

Anahatas preferred delivery approach is an iterative, agile, customer centric software development process where business analysts and developers work with the customers to gather requirements and an understanding of the current business processes, and to design and deliver a software solution that not only meets the businesss needs, but also is desgiend to improve business productivity.

Anahatas preferred technological choice is to deliver cross-platform solutions based on open standards and open source technology that ensure stability, compatibility, and security over a long application lifespan. This enables a reduction in upfront and ongoing licensing fees.

Anahata is an Oracle Certified Partner and delivers custom software solutions based on Oracle Technology, such as Java, Java Enterprise Edition, MySQL or Oracle Database. The Australian software company is a certified MYOB developer partner providing Custom Software solutions that can integrate seamlessly with any MYOB software package such as MYOB AccountRight desktop or MYOB AccountRight Live (cloud).

For more information, visit http://www.anahata-it.com.au