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

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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Marketing Product Demos & Social

Marketing Product Demos & Social
Event on 2015-10-15 18:00:00
The Marketers Unbound marketing product demos event series allows Toronto-based marketing leaders to connect with each other and learn about products that would help their brands win.   We'll have 3 marketing product demos, followed by a q&a session with the speakers:  1. ScribbleLive content marketing software, presented by account executive Joe Ward 2. Environics Analytics marketing analytics suite, presented by director of product management Teresa Sinopoli 3. GShift SEO and content optimization software, presented by to be announced  Q&A session with the speakers moderated by Francois Mathieu, marketing product manager at Uberflip. Format: 6:00 to 6:15pm registrations and social time (snacks and coffee provided) 6:15 to 6:30pm introductions (by the organizer + every attendee gets to introduce himself/herself) 6:30 to 7:10pm three product demos (each speaker will have 10 minutes for his/her presentation) 7:10 to 7:35pm question & answer session with the three speakers 7:35 to 8:00pm social time (snacks and coffee provided)   Our hashtag is #MarketersUnbound  ======================================== Organized by:  Marketers Unbound is a regular gathering of marketing leaders who help forward-looking brands who engage in presentations and panel discussions addressing today's challenging marketing environment.  Canadian Association of Marketing Professionals is a non-profit organization focused on uniting all marketers across Canada. Our mission is to create an inclusion-based network for all marketers to join, network, further their professional development, and deepen their connection to their profession.  ======================================== Venue partner: Uberflip: your content management system. Streamline content management, accelerate lead generation, and fuel marketing automation with Uberflip. ======================================== Want to present at or become a partner of the Marketers Unbound event series? Get in touch with us:

at Uberflip
135 Liberty St
Toronto, Canada

Equifax Workforce Solutions I-9 Anywhere Named a Top HR Product of 2015 by

Equifax Workforce Solutions I-9 Anywhere Named a Top HR Product of 2015 by
ST. LOUIS, Oct. 5, 2015 /PRNewswire/ — Equifax Workforce Solutions, a leader in human resource, analytics and verification services, and a business unit of Equifax Inc. (NYSE:EFX), today announced I-9 Anywhere, a cutting-edge software package enabling …
Read more on IT News Online

IBM Plans to Acquire Cleversafe to Propel Object Storage into the Hybrid Cloud
ARMONK, N.Y., Oct. 5, 2015 /PRNewswire/ — IBM (NYSE: IBM) today announced it has entered into a definitive agreement to acquire Cleversafe, Inc., a leading developer and manufacturer of object-based storage software and appliances. The acquisition …
Read more on IT News Online

Business Visionary Anthony Marlowe Launches Mass Markets: Names Jason Falco
IOWA CITY, Iowa, Oct. 5, 2015 /PRNewswire/ — NASCAR investor Anthony Marlowe has officially announced that he has repurchased TMone – the company he sold in 2013 – in its entirety. As of October 1, TMone has been renamed Mass Markets. The new …
Read more on IT News Online

Amazon, Bing, Google Product Ads Critical To Holiday Search Campaigns

Amazon, Bing, Google Product Ads Critical To Holiday Search Campaigns
Depending on the smartphone model, PLAs can take up between 25% and 45% of the "'pre-swipe' real estate" on the search engine results page (SERP), which pushes text ads and organic results further down the screen, and sometimes off the screen …
Read more on MediaPost Communications

7 Low-Hanging Fruits That Any #SEO Can Fix
If the title tag is too long, it will be truncated in the SERPs. If it's too short, you're not making full use of the tag's SEO potential. To make sure that your title tag is a good length, use Moz's title tag tool. It displays an example of how your …
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How to Give Bank CEOs More Skin in the Game
A SERP is a promise to pay the executive a meaningful portion of his or her salary throughout retirement. It is designed to influence executives' long-term behavior. Since assets cannot be irrevocably set aside to make retirement payments in the future …
Read more on American Banker

Shark Tank-Esque Product Launchers CEO Named Top 40 Under 40

Haverstraw, NY (PRWEB) June 12, 2015

Linda Parry, CEO, Product Launchers, has been named one of Westchester County Business Councils 40 Under 40 Rising Stars. The 40 Under 40 program recognizes individuals in Westchester, NY who surpass expectations, raise the bar and set new standards for success. Hundreds of nominations were submitted, only the top 40 were chosen by the Council. Parry and other winners were honored during an award ceremony last night at 800 Westchester Avenue in Rye Brook, NY.

Linda Parry, 33, is founder and CEO of Product Launchers, a marketing, sales and distribution powerhouse. “We’re a young and fast-growing company that works tirelessly to generate results. It was an honor to achieve such a distinction.”

Product Launchers, a New York-based Shark Tank alternative, works with inventors and companies to bring emerging products to market via retail partnerships, trade shows, traditional and digital marketing, social media and public relations. In addition to generating sales, the company serves as a distributor by warehousing/fulfilling orders and leveraging their existing vendor accounts.

We are inventors ourselves who have successfully orchestrated our own new product launches. We apply these proven practices to our clients inventions,” says Parry.

Product Launchers’ successes cover a wide gamut of product segments, from gourmet seafood pies and childrens step stools to womens accessories and outdoor tossing games. The company has established relationships with Walmart, Bed Bath and Beyond, Toys R Us, Whole Foods Market, Sears, Kmart, TJ Maxx, Home Depot, Tractor Supply Company and more.

Prior to Product Launchers, Parry was Senior Vice President of a global marketing firm. She possesses her Bachelor’s in Marketing/Management from Siena College, Master’s in Advertising from S.I. Newhouse School of Public Communication and Juris Doctor from Syracuse University College of Law.

For more information, please visit, email info(at)productlaunchers(dot)co or call 914-712-8824.

Online Company B&B Internet Marketing LLC Introduces New Health Product

Online Company B&B Internet Marketing LLC Introduces New Health Product
CALGARY, Canada, June 15, 2015 /PRNewswire/ — Calgary web-based company, B&B Internet Marketing LLC, today unveiled its new health product supply store at The new online store offers a select array of …
Read more on PR Newswire (press release)

These Internet Marketing Secret Weapons Will Help You Get More Sales Online
If you're looking to learn about internet marketing, you'll without a doubt find this place to be your internet marketing haven. There's just loads of things that you can learn from on this page alone. Of course, when your website has something very …
Read more on Business 2 Community

Making Links A Priority Within Online Marketing
Without links, the internet simply would not function the way it does today. If you're marketing your business online, you must account for links. Not only are links enormously important, but link acquisition itself actually fits in quite naturally …
Read more on Business 2 Community

Top of the List: Advertising, marketing, public relations, promotional product

Top of the List: Advertising, marketing, public relations, promotional product
20 Largest Public Relations Firms list is led by Edelman for the eighth year in a row. With 105 full-time employees, in addition to public relations services, the firm offers business-to-business communication, data visualization, and employee …
Read more on Atlanta Business Chronicle

Why PR gurus always print the myth
From one man and his Filofax to a global phenomenon that shapes our culture, public relations is laid bare at a new show at the V&A. For 40 years Alan Edwards has guided the brightest lights in rock, pop and celebrity and his vast collection of …

Ballantines Public Relations Wins Coveted Marriott International Lifestyle
LOS ANGELES, May 19, 2015 /PRNewswire/ — Ballantines Public Relations (BPR), the award-winning global lifestyle PR agency, is thrilled to announce that Marriott International Lifestyle Brands has chosen the company as their official international …
Read more on CNNMoney

Control Solutions adds Mosquito Mist Ultra to its already diverse vector control product line

Pasadena, Texas (PRWEB) May 24, 2015

Control Solutions adds Mosquito Mist Ultra to its already diverse vector control product line. Mosquito Mist Ultra contains 20.6% permethrin and 20.6% piperonyl butoxide (PBO), which allows the product to maximize its effectiveness against mosquito populations including species that transmit West Nile Virus. Mosquito Mist Ultra has the versatility to be mixed with both water or oil, and is designed for ultra low-volume (ULV) and thermal fogging applications.

For more information on Mosquito Mist Ultra and CSI’s vector control line, visit their website at

About Control Solutions Inc. (CSI)

Control Solutions began as a family owned business in 1958 and is built on to the commitment of serving the professional pest control and retail markets. CSI has added product lines for the Industrial, Lawn and Garden, Animal Health and Biocide markets, and is working with over 80 distributors serving those markets. Control Solutions maintains relationships with chemical manufacturers worldwide and provides a ready supply of products in distribution warehouses across the U.S. The partnership with ADAMA (formerly Makhteshim-Agan Industries) multiplies Control Solutions agility in continuously adding new products to meet the needs of professionals and homeowners. “The one constant since the beginning in 1958 is our mission focus: to seek out and distribute effective and economical solutions for our customers,” stated Mark Boyd, President and founder of CSI.

About ADAMA Agricultural Solutions

ADAMA Agricultural Solutions Ltd. is a leading global manufacturer and distributor worldwide of crop protection solutions. The Company supplies efficient solutions to farmers across the full farming value-chain, including crop-protection, novel agricultural technologies, and complementary non-crop businesses. In 2012, the Company’s revenues were over $ 2.83 billion, and it is ranked seventh in the world in the overall agrochemicals industry. The Company is characterized by its heritage of innovation, farmer-centric approach to product development, and observance of strict standards of environmental protection and quality control.

For more information about ADAMA, visit

Buzztala Intros HD Quality Product Video Ads for Search Advertising

(PRWEB) May 20, 2015

Today Buzztala announced the addition of high definition quality video ads designed for ecommerce retailers who are interested in reaching shoppers in the mobile era. Buzztala is solving a huge product search problem for top brands online. Retailers and brands spend more than $ 18B per year on search engine marketing (SEM) trying to attract customers using desktop and mobile browsers. However, this approach misses over half the intended audience as 52% of all internet time is now spent in mobile apps (primarily Facebook, Twitter, YouTube) where users prefer video content over reading on limited screens. Moreover, despite half of the U.S. Digital Ad market is spent on Search, there is still no product centric video content in this huge sector to reach these mobile + visual shoppers.

Buzztala is filling this need by rapidly building a vast library of Product Video Ads (PVAs) ideally suited for mobile consumption. At the core of Buzztala is its proprietary Product Video Ad platform that turns retailers product feeds into short hosted videos and then publishes them everywhere and anywhere people are consuming content, desktop or mobile. Buzztalas proprietary video SEO surfaces videos organically in search engine result pages (SERPs) while its platform traffics ads programmatically to boost margins and meet advertiser performance goals. The results speak for themselves: Buzztala videos average an industry leading 9.6% click through rate (CTR), 2.8% conversion rate, and outperforms Googles most effective ads by more than 4X based on current data.

The visual web is here and Facebook is a great example. The growth of Facebook has entirely shifted to mobile, and users overwhelmingly prefer video content, says Jay DeDapper, Founder and Chief Executive Officer of Buzztala. Yet while the rest of the world has embraced the mobile era, product search marketing is still done thru product feeds and static, flat image content. Buzztala is now working with some of the largest retailers in the world like Sears and Walmart to modernize their product catalogs into video so they can generate more effective campaigns from their search marketing budgets.

Product search has one-to-one mapping of products to metadata like descriptions, prices and images but not video. A lot of advertisers tell us theyre ready to change that to stay ahead of their competitors, said Henry Wong, co-Founder and Chief Operating Officer, Every month the Buzztala Platform is producing tens of thousands of videos hosted by real people talking about our clients products and services videos watched by millions of shoppers in social (Facebook, Twitter, YouTube), via organic search, and in traditional PPC campaigns bolstered with performance-boosting video links.

About Buzztala

The Buzztala Organic Video Ad Marketplace is giving brands and retailers better ROI on search marketing budgets with our Product Video Ads (PVAs). These short video product summaries capture top organic search positions and deliver industry-leading CTRs. With our technology platform and presenter network Buzztala can produce videos featuring real people at scale for millions of products — at just $ 5 per video for new Advertisers! The results speak for themselves: Buzztalas PVAs are outperforming Google search ads by 4x and deliver industry leading performance metrics.