2 Day Seminar Assuring Data Integrity in the Life Science industry (WCS)


2 Day Seminar Assuring Data Integrity in the Life Science industry (WCS)
Event on 2017-10-04 08:30:00
DescriptionCourse has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion Each attendee will receive 2-Day workshop materials ,Certificate, Complimentary Breakfast , Lunch & High Tea/Coffee provided by WCS. Data integrity continues to be one of the topmost concerns of regulators worldwide.  With regulatory agencies actively hiring computer savvy personnel, we can only expect increased and rigorous audits of data integrity. After successful workshops last year that filled to capacity, WCS is again teaming up with Chinmoy Roy to provide this all new 2-day workshop.  It focuses on emerging data integrity concepts and audit focus areas. Attending this workshop will enable attendees to not only become familiar with data integrity fundamentals and practices but to also effortlessly identify and remediate potential data integrity issues before auditors do.Addressed will be case studies, inspection approaches, trends in the issuance of data integrity 483s and warning letters in the recent past. Take back to your work, samples of Data Integrity related directives and SOPs such as Data Integrity Policy, Maintenance of Electronic Records directive and many more that are required to establish a data integrity infrastructure in your company.This workshop is for novices as well as experienced personnel from QA, IT, manufacturing, regulatory and validation groups. It addresses data integrity issues in all life science industry sectors where data is required to fulfill regulatory requirements.  These sectors include medical devices, biologics manufacturing, quality control laboratories, clinical trials, blood establishments, compounding pharmacies etc. Areas Covered          What is Data integrity         Data Life Cycle design and controls          Elements of a Data Integrity Assurance program          Roles and responsibilities of different groups in ensuring data integrity          What data integrity SOPs do auditors expect to see during audits          Validating Data Integrity Who will Benefit     Pharmaceutical industry / Medical device industry / Healthcare industry personnel     Developers of software for use in Life Sciences industry     Validation service providers, IT service providers     Manufacturing personnel, Manufacturing Automation system vendors and system integrators     Regulatory Affairs group, Quality Unit     Laboratory personnel     Users of Cloud     Clinical Trial Sponsors Some advanced Data Integrity topics include:         Data Integrity triad          Data Integrity Maturity Model          Developing critical thinking skills          Data Integrity Audit trends Course Outline: DAY ONE (08:30 AM to 05:00 PM)Module 1Data Integrity: concepts, requirements, definitions, approaches-Meaning and principles of DI-Data types and their relevance to DI-DI dimensions  Break 1Module 2Why Data integrity issues occur-What are the principal factors that cause DI issues to occur-How to proactively control these factors-Hands on: Access security & Audit Trail SOP/Directive Lunch BreakGroup exercise: DI Directives & SOPs Module 3Implement enterprise DI program-What is the 5p model for DI-DI checklist to assess DI health- What are the DI triad elements Break 2Module 4In the trenches –  implementing DI-What should a company’s DI Assurance Plan contain-What would auditors like to see in the DI directives & SOPs -What should a guidance document on how to design for and validate  DI contain  DAY TWO (08:30 AM to 04:30 PM)Module 5Data Integrity in the Laboratory-Why laboratory DI is the key focus-What are Lab DI audit trends & how to avoid them-What laboratory DI core documents that you need to keep ready for auditors Break 1Module 6DI in Manufacturing IT & Clinical trial systems-How does Sys. Architecture impact DI-What are the DI citations for DI items review in Electronic Batch records-DI susceptibilities of hybrid systems-Paper and eCRF data entry practices-What should be aware of when presenting pdf copies to regulatorsLunch BreakGroup exercise: Mock inspection audit Module 7Advanced topics-How can you effectively use your Data Integrity Maturity Model during audits-Critical thinking skills for internal auditors-What items are critical for DI audits of Clouds; SaaS/PaaS Break 2Module 8Update on current DI audit and enforcement trends using most recently issued 483’s and Warning letters Presentation of certificates Testimonials    I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.    Pfizer Quality Manager    I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."    RA/QA Manager Abbott    The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.    Chief Compliance Officer         This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.    Quality Assurance Medtronic    “I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”    Peter Belsito, Director of Quality TSI    Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir    “Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA    “I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.         “Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals         “Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.    “I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.         “Great session. I learned a lot” Chief HR Professional"    “Wow!  I had an opportunity to attend the HR audit workshop.  It is spectacular and I found it very valuable.    It will help us audit and manage strategic HR issues.” The president of a major insurance and risk management agency.    “I found the audit session very useful; it will help us identify and manage key HR management issues.” A senior auditor    “The session provided important information about HR auditing. It will help us audit critical HR issues and outcomes     and will help us assess the organization’s culture and values.” A Chief Internal Auditor    “I’ve been doing a lot of research lately on HR audits, trying to find the best system for us.    This session and ELLA seems to really fit the bill for us.” A human resource manager. Media Partners Top Media Partners and Sponsors World Compliance Seminars WCS Morf Media, Inc. is shaping the future of enterprise compliance training for the mobile workforce. For the first time, a digital compliance training system, Morf Learning™, provides one to one training to millions on a smart phone or tablet. Now in pilot with more than 100 major companies in the financial services and life sciences industries, Morf Learning is proving to be cost-effective and engaging. Morf Learning delivers three-minute mini lessons with a personalized Virtual Coach™ developed using the Octalysis framework designed by world-renowned gamification leader, Yu-Kai Chou.  Benefits of enrolling for Media Partner Your company Logo on all the mailings before and after the event. Get 10% discount to media partner's subscribers. Publish your Logo and company data on the event website. Publish your Logo on the conference material distributed during the conference. Media Partner’s brochure distributed along with conference material MEDIA PARTNERS WORK TO DO Publish Banner on the Media Partner website. Insertion of the WCS event in the event calendar, both printed and/or online. Announcement article of the conference on the Magazine and/or Website. Dedicated email blast to all subscribers Sponsors Top Sponsors for WCS – World Compliance Seminars If you wish to sponsor our event Please contact us:  partner@worldcomplianceseminars.com or speak with one of the account manager + 844 267-7299 ,000 – Silver Sponsor Package Includes Company name and logo on all materials related to events, and prominent location on WCS web site and event media releases  Listing in monthly Community Leader newsletter sent to over 50,000 users.  1 Free Pass for the 2 Day Workshop Sponsors materials will be distributed onsite to all the attendees ,000 – Silver Gold Package Includes Company name and logo on all materials related to events, and prominent location on WCS web site and event media releases  Listing in monthly Community Leader newsletter sent to over 50,000 users.  2 Free Pass for the 2 Day Workshop Sponsors materials will be distributed onsite to all the attendees 15-20 minutes product demo during the live session Boston Public Garden, Boston,MA This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden. Boston Public Library, Boston,MA The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessib Fenway Park, Boston,MA Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right Museum of Fine Arts, Boston,MA Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyp Museum of Science, Boston,MA The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space trave North End, Boston,MA This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights. Old North Church, Boston,MA The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Pa Chinmoy RoyBSEE, MSCS US FDA Expert Data integrity & CSV Subject Matter Expert: Data Integrity, GAMP, CSV, CFR 21 Part 11, Annex 11, Quality Risk Management, Manufacturing Process Automation and IT systems Chinmoy Roy has 37+ years of experience. He is an internationally recognized subject matter expert in CSV, CFR 21 Part 11, Annex 11, Data Integrity and manufacturing process automation systems. He has been invited to speak and conduct training workshops at several international conferences such as ISPE, WBF, Shimadzu’s annual conference for Asia Pacific, etc. His expertise stems from his experience in implementing and obtaining “fit for use” certification for over 200 IT systems. He has worked at and consulted with leading US based companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson etc. His pioneering efforts in implementing CFR 21 Part 11 compliant manufacturing IT systems in 1999 while employed by Genentech, was a precursor to FDA’s issuance of Part 11’s Scope and Application guidance in 2003. His workshops are unique in that he blends his field experience to provide case studies to explain the intricacies of implementing regulations. Chinmoy is an Electrical Engineer and a Computer Science post graduate. Please contact the event manager Marilyn below for the following: – Discounts for registering 5 or more participants.- If you company requires a price quotation.Event Manager Contact: marilyn.b.turner(at)nyeventslist.comYou can also contact us if you require a visa invitation letter, after ticket purchase. We can also provide a certificate of completion for this event if required.NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS —————————————————————–This Event Listing is Promoted  byNew York Media Technologies LLC in associationwith WCS Consulting Inc.http://www.NyEventsList.comhttp://www.BostonEventsList.comhttp://www.SFBayEventsList.com—————————————————————–"                SON170605CEV    

at Hilton Garden Inn Boston Logan Airport
100 Boardman Street
Boston, United States

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