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

Digital Marketing Conference Philippines 2017 DMCON4

Digital Marketing Conference Philippines 2017 DMCON4
Event on 2017-08-12 09:00:00
The DIGITAL MARKETING CONFERENCE PHILIPPINES 2017 DMCON4 is a seminar thoughtfully designed to make marketers learn the basics and get ahead with Digital Marketing all in one day!

The event will be held on AUGUST 12, 2017 at the MUSIC MUSEUM, Greenhills, San Juan City.

at Music Museum
Level C – Shoppesville Arcade Greenhills
Manila, Philippines

January Camp Optimization

January Camp Optimization
Event on 2016-01-28 16:30:00
This month Ryan Campell joins Camp Optimization from Add3 to talk on behalf of pay per click marketing. PPC is one of the most measurable digital marketing channels available. Come learn actionable strategies and tactics you can implement to take your optimization campaigns to the next level. Ryan has been leading and managing digital marketing campaigns for almost 10 years. He's optimized campaigns as an in house manager and now, at an agency. Ryan has a deep passion for performance based digital marketing and is an expert in paid search, SEO, and paid social media. We will be meeting at Baerlic Brewing Company for some beer and casual networking. First round of beer is on us! Add3 is a digital marketing agency that delivers integrated digital marketing campaigns across search, social & display advertising, helping our clients reach their marketing goals.   What is Camp Optimization? Camp Optimization's mission is simple: provide a casual, fun and informative forum for digital marketers and technologists to share optimization best-practices, challenges and wins. Who is roboboogie? Roboboogie is a Portland-based customer experience optimization agency partnering closely with brands to improve conversion rates, nurture brand advocacy and increase customer value.

at Baerlic Brewing Company
2235 Southeast 11th Avenue
Portland, United States

Crawford/Verdejo: Top Rank Moves Forward With 2/27 Double

Crawford/Verdejo: Top Rank Moves Forward With 2/27 Double
The unbeaten two-division title claimant will appear alongside rising lightweight contender Felix Verdejo in a Feb. 27 HBO twinbill at Madison Square Garden Theatre. Top Rank confirmed to of plans for the show, which was first reported …

Top Rank Won't Market April 9 As Pacquiao's Last Fight
As boxing awaits the official announcement of Manny Pacquiao's next – and perhaps final – opponent, his team prepares for what they plan to be a major event. What has been confirmed so far is that the former eight-division champ will return to the ring …

ALA to team up with Top Rank
LAST year was a banner year for ALA Promotions as the Cebu-based promotional outfit staged boxing events in the Philippines, a second show in Dubai and a first in the US. This year promises to be another huge year for ALA Promotions as president …
Read more on Sun.Star

1/12 Lexington – Search Engine Optimization Tips – The basics of SEO for Small Business

1/12 Lexington – Search Engine Optimization Tips – The basics of SEO for Small Business
Event on 2016-01-12 09:00:00
Search engine optimization (SEO) has been a mystery to most for many years but the latest trends may have made the process simpler. This course will provide the latest information on SEO and how the average business owner can control their own destiny on the search engines.

at Lexington Chamber of Commerce
311 West Main Street
Lexington, United States

Workshop on marketing for small businesses set for Sept. 24

Workshop on marketing for small businesses set for Sept. 24
A seminar on marketing for small businesses is the first in a series of four workshops focused on the challenges and opportunities facing independently owned and operated enterprises. Named the Conway Small Business Institute, the series is a …
Read more on Log Cabin Democrat

All Ships Rise with the Tide: How Marketing Can Be the Wave to Success
One of the biggest questions we get from our law firm clients is, “How do we get the most out of our marketing dollars?” Of course, the answer can vary, but one way seems so obvious that I'm surprised more firms aren't taking this approach. What if we …
Read more on The National Law Review

Why "Digital Marketing" Isn't as High-Tech as You Think
See, the core of the inbound marketing ideology is that it's all about the consumer. And since our clients and their products are especially focused on customer relationships, we take particular care to ensure that any online marketing materials we …
Read more on Business 2 Community

New Apple TV tries to snatch the control from Google, Roku, Amazon

New Apple TV tries to snatch the control from Google, Roku, Amazon
Google's Chromecast, which plugs into the back of a television, is $ 35. The new Apple TV will include an App Store and a new remote control that responds to touch. With it, viewers can slide through a thumbnail display of movies, for example, or fast …
Read more on CNET

iPhone 6S: 3D Touch will have Google feeling the pressure
I HATE TWITTER. I mean, obviously I love Twitter really, but during and after an Apple announcement it becomes the worst. Besides, Great British Bake Off spoilers, remarks such as "OMG what is this 2012? #TeamAndroid" and "LOL Hey Siri tell us …
Read more on Inquirer

This story made a bunch of Google families cry during its 3rd annual Take Your
The tradition started casually in Google's India office a while ago, but first became a big event at its headquarters in 2012, when Google invited parents from all over the world to come “peel back the curtain” by exploring the campus, checking out a …
Read more on Business Insider Australia

Baseball America Names Allison Top PL Prospect

Baseball America Names Allison Top PL Prospect
Baseball America Names Allison Top PL Prospect … The accolades for Western Michigan baseball's Tanner Allison continue to roll in, as Baseball America named him the top prospect in the Prospect League in 2015. The sophomore left-handed pitcher was …

Who's online right now? The public can track which federal Web sites are most
By 11:04 a.m. Friday, 2,703 people had clicked on the Web site for the National Weather Service, which warned of tropical storms heading toward the Florida coast and more wildfires in Montana, Idaho and Wyoming. That was the most popular federal site …
Read more on Washington Post (blog)

A Guide to the Dark Web's Lighter Side
That underground warren of anonymous sites known as the dark web has a reputation for nightmarish stuff like child porn and hit men for hire. It does indeed contain those horrors—and a lot of perfectly decent things. Fire up your Tor browser and …
Read more on Wired