Computer System Validation

About GlobalCompliancePanel:GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient. GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place. Through our trainings, we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn or be aware of those regulations, on the other.Our services benefit the Medical Devices, Pharmaceutical, Bio Technology, Food Safety, Financial Accounting Standards, and IT Control & PCI Industries. Our clientele includes companies such as J&J, Pfizer, Sanofi Aventis, Pall Corp, Abbott, Merck, Bayer, and Roche, some of which are Fortune 500 companies. P ro fess iona l s who unde rgo t ra in ings f rom GlobalCompliancePanel exhibit a vastly improved quality of life in which there is increased productivity and professional growth. Some 30,000 professionals have gained from more than 500 training courses we have conducted till nowNet Zealouswww.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.2-day In-person Seminar:Computer Systems Validation to Avoid 483s Data Sheet By: CEO, Touchstone Technologies Silicon Valley . Angela BazigosGlobalCompliancePanelCourse "Computer Systems Validation to Avoid 483s Data Sheet" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recerti?cation upon full completion. Location : Los Angeles CA | March 20-21, 2014www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.Angela Bazigos, CEO, Touchstone Technologies Silicon Valley.2-day?In-person?Seminar?2014Ms.Angela Bazigos, The CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Ms Bazigos is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to investment groups on Lifesciences investments as well as Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. Day One Day Two Course Outline:GlobalCompliancePanelOverview:Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry . It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. The latter impact all areas of ICH Q9 and ICH Q10. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV.Lecture 1: Introduction / Background? Introductions / Participants' Understanding / Participants' Objectives for the Course (Please come prepared to discuss) ? Overview of Life Sciences Lifecycle (ICH Q10) and how CSV ?ts into it ? Detecting CSV in predicate rules / guidances ? CSV in 21 CFR 11 / Annex 11 ? The FDA,s 21 CFR 11 Add-On Inspections Lecture 2: CSV at a High Level? CSV: It's Easy Really ? CSV components and deliverables ? CSV & ICH Q9 (Risk Assessment) Lecture 3: CSV Detailed Study? Validation Plan ? Requirements Speci?cations ? Functional Speci?cations ? Exercise on how to create requirements Lecture 4 : CSV Detailed Study (Cont'd)? Design Speci?cations ? Software Con?guration and Build ? Traceability Matrix? Veri?cation and Testing ? Validation Report ? Validation Registry ? CSV for Excel and other spreadsheetsLecture 5 : CSV implementation in Cloud? Regulatory Compliance for the CloudLectrure 6 : Business Continuity? Implementing Business Continuity for CSV Lecture 7: Project Management & QA? Project Management for CSV ? How to audit CSV projects Lecture 8 : 483s & Warning Letters? What are 483s & Warning Letters (and other Regulatory Citations) ? How to Respond to CSV related citations following an inspectionMore recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley's Business School for Executive Education in Life Sciences and on the Stanford Who's Who Registry for contributions to the Lifescience industry. The Seminar: :This Hands-On course will provide the attendees with both a strategic and a tactical understanding of how CSV ?ts into all aspects of the Life Sciences Industry and how to implement CSV to ensure successful inspections. It will address the following topics: 1.CSV in the Life Sciences Industry: What it is, where to ?nd requirements in other guidances including 21 CFR 11 & Annex 11, how it ?ts in with ICH Q9 and ICH Q102.How to implement CSV 3.How Cloud, , Patient Con?dentiality are impacted 4.CSV & Business Continuity 5.483s & Warning Letters and how to respond to CSV related citations 6.How to have a successful FDA inspection www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.2-day?In-person?Seminar?2014**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.Price for One Delegate pass Price: $1,295.00Pricing list:1. Learning Objectives2. Participation certificates3. Interactive sessions with the US expert4. Post event email assistance to your queries.5. Special price on future purchase of web based trainings.6. Special price on future consulting or expertise services.7. Special price on future seminars by GlobalCompliancePanel. 8. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog, notepad and pen.9. Networking with industry's top notch professionalsWhat you get? Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link? Check: Kindly make the check payable to NetZealous DBA GlobalCompliancePanel and mailed to 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA? PO: Please drop an email to support@globalcompliancepanel.com or call the our toll free 1800 447 9407 for the invoice and you may fax the PO to 302 288 6884 ? Wire Transfer: Please drop an email to support@globalcompliancepanel.com or call our toll free 1800 447 9407 for the wire transfer informationPayment Options:Who Should Attend:Contact Information: Event CoordinatorToll free: 1800 447 9407 Fax: 302 288 6884Email: support@globalcompliancepanel.comNetZealous LLC, DBA GlobalCompliancePanel161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USAKindly get in touch with us for any help or information.Look forward to meeting you at the seminarTeam GlobalCompliancePanelGlobalCompliancePanel? VP of IT? Director of IT? Quality Managers? Project Managers (for CSV / IT)? Validation Specialists? Database Administrators? System Administrators? Directors / Senior Directors of Discovery? Pharmaceuticals? Biotech? Medical Device? Radiological Health? Blood Products? Companion Animals? Food? CosmeticsRegister now and save . (Early Bird)$200Until February 25, Early Bird Price: $1,295.00$1,495.00From February 26 to March 18, Regular Price: March 20-21, 2014 | Los Angeles CA Industries:www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.Registration :FormPlease use this form to register online, using your American Express, Visa or MasterCard.To get discounts on group attendance, please call us on1800 425 9409Call us on 1800 447 9407 or fax your PO to 302 288 6884Please pay your check issued from the payee to NetZealous LLC, our parent company, and mail it to NetZealous, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Please call us at or email us at Please ?ll this form out and include 100 8425 9409 support@globalcompliancepanel.comattendee and payment details in it and fax it to 302 288 6884Terms and ConditionsYour registration for this seminar is bound by terms and conditions spelt out here. Please call or mail us if you have any clari?cations or doubts on this issue.Cancellations and SubstitutionsIf you wish to cancel your attendance at our seminar, the person who has registered for this seminar has to submit written cancellations through fax or email at least 10 calendar days before the date of commencement of the event. This will entitle her/him to a full refund minus a $150 administration fee. No cancellation request will be accepted or entertained and no refunds will be issued for requests made outside the stipulated period.A request to this effect has to be sent by email or fax more than ten days before the commencement date of the seminar. After receiving this request, we will issue a credit for the amount paid with a deduction of administration fees of $150. This credit note will be transferred to a future GlobalCompliancePanel event, and a credit note will be issued towards this.You are allowed to make substitutions at any time till the start of the event. The substituting person should be present well in time for the event with proper written communication and company identity.If registering on the date of the seminar, please make sure you pay for the event using your credit card or check just before the start of the event. To such attendees, we may not be able to give the conference materials on the spot. In such an event; we will send the same after the conclusion of the seminar.No-shows will not be reimbursed.If GlobalCompliancePanel cancels an event, we will not be reimbursing any airfare, accommodation, other costs or losses that the registrants may have incurred. 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Bill me/my company $ ............................................................Purchase order # ........................................................................(Payment is required by the date of the conference.)Please ?ll this form with attendee details and payment details and fax it to 302 288 6884NetZealous LLC, DBA GlobalCompliancePanel161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USAPhone: +1-800-447-9407Toll free (US): +1-800-447-9407 / Fax (US): 302 288 68842-day?In-person?Seminar?2014GlobalCompliancePanel