Software Validation for the New FDA Inspections

2-day In-person Seminar:Net ZealousAbout GlobalCompliancePanel:GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-e f f e c t i v e w h i l e b e i n g c o n v e n i e n t . 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.www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.Our services benef i t 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. Profess iona ls who undergo 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 nowBy: David NettletonLocation: Singapore | December 5-6, 2013www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.David NettletonFDA Compliance SpecialistAbout Speaker:David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is Risk Based Software Validation - Ten easy Steps. It relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 225 mission critical software validation projects. Lecture 1: Introduction to the FDA ? How the regulations help your company to be successful? Which data and systems are subject to Part 11.Lecture 2: 21 CFR Part 11 - Compliance for Electronic Records and Signatures ? What Part 11 means to you, not just what it says in the regulation.? Avoid 483 and Warning Letters.? Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation.? Ensure data integrity, security, and protect intellectual property.? Understand the current computer system industry standards for security, data transfer, and audit trails.? Electronic signatures, digital pens, and biometric signatures.? SOPs required for the IT infrastructure.? Product features to look for when purchasing COTS software.? Reduce validation resources by using easy to understand ?ll-in-the-blank validation documents.Lecture 3: HIPAA Compliance for Electronic Records ? How Part 11 and HIPAA interrelate? What are the additional requirements for patient dataLecture 4 : The Five Keys to COTS Computer System Validation ? The Who, What, Where, When, and Why of CSVLecture 5 : The Validation Team ? How to select team members? How to facilitate a validation projectLecture 6: Ten-Step Process for COTS Computer System Validation? Learn which documents the FDA expects to audit.? How to use the risk-based validation approach to lower costs.? How to link requirements, speci?cations, risk management, and testing.? Document a computer system validation project using easy to understand ?ll-in-the-blank templates.? Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).Lecture 7: How to Write Requirements and Speci?cations ? Workshop for writing requirements and then expanding them for speci?cationsLecture 8: How to Conduct a Hazard Analysis/Risk Assessment-Exercise ? TStep-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.Lecture 9 : Software Testing? Reduce testing by writing test cases that trace to elements of risk management.? How to write ef?cient test casesLecture 10 : System Change Control ? How to manage a validated system with minimal documentationLecture 11 : Cost Reduction Without Increasing Regulatory or Business Risk ? How to save money? How to increase quality? How to increase compliance with less documentationLecture 12 : Q & A AGENDADAY ONE DAY TWO 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 professionalsWho Will Benefit: ? IT? QA ? QC ? Laboratory staff ? Managers? Regulatory Affairs? GMP, GCP, GLP professionals Price for One Delegate pass Price: $1,595.00**Please note the registration will be closed 2days (48 Hours) prior to the date of the seminar.Payment Options:? 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 informationContact 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 GlobalCompliancePanelRegister now and save $200. (Early Bird)Until October 21, Early Bird Price: $1,595.00From October 22 to December 03, Regular Price: $1,795.00 December 05-06, 2013 | Singaporewww.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.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 6884