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

HiP Successfully Launches Same-Day Call Verification for All Leads Delivered

Albany, NY (PRWEB) August 27, 2014

Today, HiP, a B2B digital marketing agency focused on lead generation, announced full-scale deployment of its same-day call verification service. In order to confirm key contact information, including phone number and title, leads will now be called by a member of HiPs entirely US-based call verification (CV) team within 24 hours of delivery. Originally announced in late May, the new service will be extended to all customers at no additional cost. HiP anticipates the service will pay for itself through diminished lead returns and improved customer relationships.

On the subject of HiPs call verification service, HiP Founder and CEO Bret Smith said, Its a singular feature that sets us apart from our competitors who are using a combination of list hygiene and attrition to ensure the validity of their records. Our clients know that they are getting the most complete, up-to-date, and accurate lead records available. He went on, Call verification, paired with our SMTP-validated email addresses, aggressive list hygiene, and industry-leading Database Quality Standards, allow us to reduce and eventually eliminate time-consuming lead returns and the associated headaches for both lead buyers and sellers.

Early call verification outcomes are encouraging, with HiPs historic 6.4% average return rate dropping below 2%. The company anticipates that this rate will continue to fall for an overall drop of 75% or more. Anecdotal evidence from clients is equally positive. If trends continue in this direction, as Smith believes they will, HiP will have no trouble covering the six-figure annual cost of the service.

About HiP:

Founded in 2009, Albany, NY-based High-Impact-Prospecting, Inc. provides agile, single-vendor, and outcome-oriented B2B demand generation services for technology-centric clients. Key differentiators of HiP include its custom email service platform, virtual call center, 65+ million record contact database, and tight-knit team of deeply experienced US-based professionals. Its services include Email Marketing, 1:1 Lead Creation, Trade Event ROI Enhancing, B2B Social and Media Engagement, Content Creation, B2B Contact Data, and Marketing Automation Services.

fishbat, A Leader in Long Island Advertising Agencies, Discusses Twitters New Age Verification System

Bohemia, NY (PRWEB) December 06, 2013

fishbat, a leader in Long Island advertising agencies, responds to an article published by Mashable that discusses a new age verification system developed by Twitter that prevents underage youths from following alcohol brands the social media platform.

According to the article published by Mashable on November 26th titled, Twitter’s Age Verification System Wants to Keep Kids Away from Booze, Twitter recently made changes to its platform to deter underage fans from following alcohol brands. Now, in order to follow alcohol companies, users must fill out a message that requires them fill in their birthday. If users fail to supply an age within a 24-hour period, they will not be able to follow that brand.

The article says popular brands such as Heineken, Bud Light, and Bacardi have already signed onto the verification system, and clients that wish to introduce the age verification process into their accounts are able to do so by contacting their account support.

The new feature is supported on Twitters web page and on all iOS and Android devices.

Twitter spokesperson Tarun Jain explains Twitters reasoning behind the verification system,Our hope is that this approach to age-screening will enable alcohol brands to responsibly and safely connect with the right audiences on Twitter.

Justin Maas, vice president of client relations at fishbat, a leader in Long Island advertising agencies, echoes Jains sentiments. When it comes to alcohol, I think its necessary to utilize social media safeguards so that the company isnt reaching undesired markets, he says. Social media platforms such as Tumblr and Facebook have successfully implemented similar programs that allow them to uphold the responsible reputations they maintain. I think its just a matter of time before every social media platform enforces a similar system.

Maas says that the beauty of having an age restriction system is that it places responsibility upon the individual user. Because it exists online, theres never going to be a perfect system of identificationa 15-year-old can easily claim they are 21, he says. However, the ingenuity of an honors system is that the burden of responsibility shifts from the social media platform to the individual. If the system breaks down, the fault lies with the individual, not the social network.

fishbat is a full-service online marketing company and social media agency dedicated to connecting all types of businesses with their target audiences in the most effective and efficient way. Through innovative strategies in social media management, search engine optimization (SEO), branding, web design, reputation management and public relations, fishbat promotes a consistent and professional online voice for all of its clients.