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- Contact us today! NetZealous LLC DBA GlobalCompliancePanel Toll free: +1-800-447-9407 Phone: +1-510-584-9661 Website: Registration Link – Follow us on LinkedIn: Like us our Facebook page: Follow us on Twitter: Seminar Fee for One Delegate – 95.00

at The Hilton Garden Inn
Saint George, United States

Chuck Wang: Online Entrepreneur, Marketing automation Architect, Internet Business Coach, Sales Strategist. Ask me about Survey Funnels, Click Funnels, Email marketing, CRMs, Audience Creation, Publishing tips, Business Success. – MVP Marketing | is a process. What is your MOST VALUABLE PROCESS?

Chuck Wang: Online Entrepreneur, Marketing automation Architect, Internet Business Coach, Sales Strategist. Ask me about Survey Funnels, Click Funnels, Email marketing, CRMs, Audience Creation, Publishing tips, Business Success. – MVP Marketing | is a process. What is your MOST VALUABLE PROCESS?
from MVP Marketing | is a process. What is your MOST VALUABLE PROCESS?
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DoInbound: Project and Process Management Software for Inbound Marketing Agencies – Inbound Agency Journey: Inbound Marketing | Content Marketing | Agency Growth

DoInbound: Project and Process Management Software for Inbound Marketing Agencies – Inbound Agency Journey: Inbound Marketing | Content Marketing | Agency Growth
from Inbound Agency Journey: Inbound Marketing | Content Marketing | Agency Growth
Price: USD 0
View Details about DoInbound: Project and Process Management Software for Inbound Marketing Agencies

Soapbox: CSU shared governance process misaligned

Soapbox: CSU shared governance process misaligned
… benefited from the work of the American Association of University Professors (AAUP), a national Best Practice Organization for tertiary education in America and leader in advancing values that make America's universities top rank of universities …
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Hospitals in the city may treat stars, but they struggle to earn them
A world-class institution that counts princes and presidents among its patients, New York-Presbyterian failed to score a top rank of five stars under a new system used to rate patient satisfaction by the Centers for Medicare & Medicaid Services. And it …
Read more on Crain’s New York Business

Crawford-Dulorme Early Results from Arlington, Texas
Middleweights Eddie Tigs (1-5-3) and Mike Tufariello (4-2-2, 4KO) battled to a 4 round draw in the opening bout of the Crawford vs. Dulorme world title clash for the WBO Jr Welterweight crown in Arlington, Texas. An apparent knockdown by Tigs in the …
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MicroTec for Windows: Semiconductor Process and Device Simulator

Waterloo, Ontario (PRWEB) February 28, 2015

After its first public release in early 90’s MicroTec semiconductor device simulator was used for research and education in more than 30 countries. More than 130 schools including leading academic institutions, such as Tokyo Institute of Technology, University of California at Berkeley, Waseda University, University of Waterloo, etc. The software is designed as an addition to any book on semiconductor devices or processes. It allows students to virtually create devices using a realistic semiconductor processing flow and then test their performance. A limited version of MicroTec was published by John Wiley & Sons as a supplement to Semiconductors Devices Explained by Prof. Ton Mouthaan’s from the Twente University. Another example of how MicroTec could be used with a text book on Semiconductor Devices is presented here for a popular book by Ben Streetman and Sunjay Banerjee Solid State Electronic Devices.

MicroTec is somewhat simplified compared to other TCAD tools, but was nevertheless used by 30+ semiconductor companies including leading semiconductor manufacturers such as Hitachi, NTT, Matsushita, National Semiconductor, General Electric, Texas Instruments and Integrated Device Technology. MicroTec is particularly efficient for computationally extensive simulations of power semiconductor devices with large dimensions where it may outperform most of the commercial TCAD tools. MicroTec is remarkably stable for devices made of wide bandgap materials such as SiC, GaN and others. This is why it had been used for a few years for SiC device simulation at Cree Research. Lately MicroTec has become a simulator of choice for Solar Cells due to its robustness for large area devices.

The most critical feature of MicroTec is its robustness, semiconductor engineers very well know how frustrating convergence problems can be and how much time can be wasted to finally get a desired IV-characteristic. It is also very user-friendly and needs very little memory. For educational use, the main MicroTec feature is ease-of-use. The newly released version of MicroTec has new features such as non-planar semiconductor device modeling capability, parameterized simulation runs, graphical device structure editor, etc.

Demo of the latest version of MicroTec is available at our download page. The graphical user fully functional, users are able to create their own projects but they can only run simulation of demo MOSFET example.

MicroTec includes SiDif for 2D semiconductor process simulation including implantation, diffusion, oxidation and epitaxy and SemSim for steady-state 2D semiconductor device simulation including MOSFET, DMOS, SOI-MOSFET, JFET, IGBT, BJT, Schottky devices etc.

With all its simplicity MicroTec meets basic requirements for semiconductor process/device design and is equipped with efficient and flexible graphics tools. It is easier to use than other tools of its kind. MicroTec is a tool helping to understand physics of semiconductor devices without extensive knowledge of computers or numerical methods and does not require much time for learning its capabilities and interface. MicroTec is an excellent tool for R&D engineers, managers, professors, students and researchers and can be referred to as a TCAD calculator.

Top MicroTec is based on the diffusion-drift model and employs finite difference technique on a rectangular, auto-generated mesh.

MicroTec-4.23 is a 32-bit semiconductor process and device application for Windows 2000, XP, Vista, Windows 7 and Windows 8 and can be run on any PC. There is no memory threshold for MicroTec-4.23 due to dynamic memory allocation, so it can be used even on a computer with only a few Mbyte memory if a modest size mesh is used.

MicroTec-4.23 semiconductor device simulation tool SemSim requires about 8 Mbytes of memory for a 20,000 node mesh. Typical CPU time for one I-V point is less than 20 seconds on a typical PC when using mesh with 6,000 nodes.

For the process simulation tool, SiDif, 4 Mbyte memory is needed for a 20,000 node mesh. A typical fabrication process simulation requires about 1 minute CPU time.

Siborg also continues its work on Smart Tweezers like type of LCR-meters.

About Siborg Systems Inc.

Established in 1994, Siborg Systems Inc. is a source of engineering software and hardware tools for the semiconductor and electronics industry. Located in the city of Waterloo, Ontario, Canada, it enjoys being a part of the local world renowned high-tech community.

For more information

Siborg Systems Inc.

24 Combermere Crescent

Waterloo, Ontario


N2L 5B1

Tel: 519-888-9906

Fax: 519-725-9522


Digi-Me and iHire Partner to Deliver a More Positive, Informed Experience During the Job Application Process

Aurora, IL (PRWEB) March 25, 2015

Digi-Me and iHire have formally partnered to launch the new Candidate Expectation video offering from Digi-Me, making it available to employers using iHire’s specialized job boards.

Digi-Me’s Candidate Expectation video solution was created to save recruiters time that was previously spent notifying individual candidates of their status during the job application process. The short, customized videos help to set job candidate expectations for the hiring process, leaving them with a clear understanding of timing and next steps, as well as providing a positive experience during their interaction with a potential employer’s brand.

“Our Candidate Expectation videos eliminate the number one frustration for job candidates: feeling like they are in a black hole after submitting an application,” said Lindsay Stanton, Chief Client Officer of Digi-Me. “This unique video solution allows employers to bridge the communication gap between recruiters, who are frequently overwhelmed by the high number of candidates to manage, and job seekers who are too often left uninformed about their application status.”

“As a leading innovator in our industry, iHire is excited to be working with Digi-Me and their cutting-edge technology,” said Tim Hawk, iHire’s Business Development Director. “Digi-Me’s video and technology solutions are revolutionizing the market for both recruiters and job applicants and we are excited to provide the first-ever Candidate Expectation video to our clients.”

Visit to learn more about Digi-Me’s Client Expectation video solutions. To learn more about iHire’s employer services, visit

About Digi-Me

With our short, customized recruitment videos spotlighting career opportunities and corporate culture, Digi-Me, a JSTN company, delivers information to job-seekers in a way that is more engaging & more accessible across all media platforms and devices. Our professional-quality video solutions include the latest cloud-based tracking technology for up-to-the-minute reporting on candidate behavior as well as automatic integration into your ATS. Harness the power of video to boost SEO, improve candidate self-selection, and stand out from the competition with Digi-Me video solutions. Learn more at

Press Contact:

Allison Sima, Interactive Marketing Manager, Digi-Me

Phone: 630-780-9454 | Email: asima(at)digi-me(dot)com

Thought For Food & Son Introduces New Social Media SMART Process for Food Companies

Marlborough, MA (PRWEB) March 17, 2015

Thought For Food & Son, a leading creative boutique that specializes in the food industry announced today they have formally introduced their new SMART Process, an acroman for Social Media Attracts Responsive Targets for food companies. The new process is a fast-track process that allows Thought For Food & Son to quickly get to the heart of food companys social media requirements quickly and efficiently. Thought For Food & Son then translates that learning into social media tactics to build relationships with their existing fans and engage new fans that will increase their social authority, generate more sales and create a community of brand advocates.

Our new SMART Process takes into account the social media platforms that should matter to food companies. Not all social media platforms are appropriate or needed for food companies to communicate with their customers, said Alan A. Casucci, managing director of Thought For Food & Son. Our process identifies which platforms should be used, then we create social media strategies that allow us to build real time and lasting relationships with their customers.

Thought For Food & Sons new SMART Process is a strategic four step process that clearly identifies the clients social media objectives and uncovers the emotional drivers needed to motivate consumers to participate in their social media out-reach. Thought For Food & Sons SMART Process totally removes the guesswork from their clients social media efforts. Therefore, it ensures that the dollars spent have a maximum impact, and focuses on delivering tangible results.

At the completion of the process, Thought For Food & Sons strategic Social Media Plan incorporates all the information learned regarding the clients competitors, targeted audience, thought leaders and products. The plan focuses on strategies that have the greatest short-term and long-term impact among all targeted groups within their marketplace. The plan details strategies and tactics that will increase their social authority, generate more sales and create a community of brand advocates. The plan also includes what SEO improvements are needed to improve their company website rankings.

We know that there is a real need for our SMART Process in the food industry. Most food companies that think that social media is posting something on their Facebook page or sending out a tweet. They dont understand the power that social media can bring to their marketing mix, stated Casucci.

Thought For Food & Son has worked with both large and small food companies such as Sea Watch International, Bakery On Main, SuperSeedz, Raw Seafoods, famous Hollywood actor Paul Sorvino Foods, Maristellas Fine Foods, New York Ravioli & Pasta Company, 505 Southwestern Sauces, New England Natural Bakers, K&B Seafood, Paesana Italian Products, Aurora Products, Big League Chew, Fonterra Brands, De Cecco Pasta and Dells Maraschino Cherries.

About Thought For Food & Son, LLC

Founded in 2005, Thought For Food & Son, LLC is a leading creative boutique that specializes in the food industry. We offer our clients a combination of expertise and value that is unsurpassed within the food industry. Were a communications company without the traditional agency BS. Thought For Food & Son operates as a Strategic Resource for its clients offering public relations, social media, packaging design and brand development. Our focus is to create communication strategies using our proprietary PR FOOD MEDIA INDEX for clients who believe in powerful thinking. Thinking that demands notice. The kind of thinking that inspires people to take action and enables our clients to grow and prosper. For more information about Thought For Food & Son e-mail

VASTEC Develops New Process to Improve Section 508 Remediation and

VASTEC Develops New Process to Improve Section 508 Remediation and
Tampa, FL, January 18, 2015 –(– VASTEC, an industry leading provider of document scanning and hosting, data transformation, and electronic information accessibility, is proud to announce it has been awarded a U.S. patent for a process that …
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UAE signs m contract with PR firm for US lobbying services
… 2017 and will include a "comprehensive public diplomacy and communications program to enhance awareness and understanding of the UAE among American policymakers and opinion leaders," according to details published on an online PR website.