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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-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.www.globalcompliancepanel.in All rights are reserved © GlobalCompliancePanel.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. Professionals who undergo trainings from 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 now.By Dr. Steven S. Kuwahara, Founder & Principal, GXP Biotechnology, LLC Location: Mumbai Date: 11th, & 12th, 2013November Dr. Steven S. Kuwahara,Founder & Principal, GXP Biotechnology, LLCAbout Speaker:Dr. Steven S. Kuwahara Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals.Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories.Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production. www.globalcompliancepanel.in All rights are reserved © GlobalCompliancePanel.Day 1 - 11th November 2013Lecture 1: Development and Effective Implementation of a Cleaning Validation Program.? FDA Requirements and Industry Standard Practices ? How to review your cleaning procedures - selection of cleaning agents and parameters? How to Develop a Cleaning Validation Policy/Program? How to Develop a Cleaning Validation Plan ? Information required? Analytical Method development and validation ? How to select challenge conditions and determine acceptance criteria application of a matrix approach, worst case selection, determination of the sampling plan and limit calculations Lecture 2: Regulatory Hot Topics related to Cleaning Validation? Documentation requirements – protocols and reports ? Calculation of Residual Limits? Execution of the CV protocols, reporting of results and handling of deviations? Holding Times? Campaign ChallengeLecture 3: Other Regulatory Hot Topics ? Monitoring and Change Control? Cleaning validation de?ciencies observed by the regulatory inspectors? The Future of cleaning and cleaning validationLecture 4: Pharmaceutical process validation lifecycle approach? Historical Background? The three phases of the Process Validation Life cycle: ? Process Design,? Process Quali?cation (Con?rm) and Continued Process Veri?cation (Monitor and Assess)? The pharmaceutical development process - identify and control the critical sources of variation? Application of Risk Management and QbD Principles Course Outline:Day 1 - 12th November 2013Lecture 5: Continued Process Veri?cation – how to monitor, analyze the data and implement changes to achieve continuous improvement.? Effective Technology Transfer ? Knowledge Management? Implementation – Process Validation Policy? Selection of characteristics to monitor and sampling frequency and quantity? Selection of tools to analyze data and frequency of analysisLecture 6: Regulatory Hot Topics related to Cleaning Validation? How to determine actions as a result of the analysis to achieve process improvements? Application to existing processes ? Legacy products and processes. Lecture 7: Overview of Problem Solving and Investigation methods.? Brain storming and writing.? Decision making with Designed Experiments.? Cause and effect, Fishbone, and Ishikawa Diagrams? Fault Tree Analysis and Failure Modes and Effects Analysis? HU and TRIZLecture 8: Brain Storming and Writing? What are the problems? The good, the bad, and the ugly.? Effective procedures. All is not lost.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 professionalsProfessionals who will benefit: ? Directors? Managers? Supervisors, and lead workers in Product Development? Regulatory Affairs? Quality Assurance and Quality Control.? Workers in Development? Production and Quality Control who may be chosen to participate in an audit either as auditors or auditees.? Workers who will be a part of the contracting process.What you get:Price for One Delegate pass Price: 18,000.Register now and save 2,000. (Early Bird)Until October 10, Early Bird Price: 18,000.From October 11 to November 10, Regular Price: 20,000.November 11th & 12th, 2013 MumbaiPayment 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 Services India Pvt. Ltd. GlobalCompliancePanel and mailed to Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar, Bangalore - 560078 Karnataka, INDIA ? PO: Please drop an email to customersupport@globalcompliancepanel.com or call the our toll free 1800 425 9409 for the invoice and you may fax the PO to 080-25149544 ? Wire Transfer: Please drop an email to customersupport@globalcompliancepanel.com or call our toll free 1800 425 9409 for the wire transfer informationom or call our toll free 1800 447 9407 for the wire transfer informationContact Information: Event CoordinatorToll free: 080-3247-3696Fax: 080-25149544Email: customersupport@globalcompliancepanel.comGlobalCompliancePanelNetZealous Services India Pvt. Ltd.Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar, Bangalore - 560078 Karnataka, INDIAKindly get in touch with us for any help or information.Look forward to meeting you at the seminarTeam GlobalCompliancePanelwww.globalcompliancepanel.in All rights are reserved © GlobalCompliancePanel.GlobalCompliancePanelSignature & Date(I hereby agree to the terms and conditions mentioned below)Please send DD/cheque payable to “NetZealous Services India Pvt. Ltd.”Service Tax registration number: AADCN6908QSD001 / PAN Number: AADCN6908QTopic: Validations and Resolving Problems Related to ThemDates: November 11th and 12th, 2013Conference timings: 9:00 am - 6:00 pmVenue: at The LaLiT Mumbai Sahar Airport Road, Andheri East, Mumbai - 400059Details of the Seminar:Please fill out the following details:Your office address:- ______________________________________________________________________Payment: (To include details)* Price does not include taxes. 12.36% taxes will be included in final amount.10% discount on group of 5 or more.* Note: Please make the cheque for total amount which includes tax.Payment byCheque : _____________________________________________________________Demand Draft : ________________________________________________________(Cheque No.)(DD No.)Name Designation Department Phone EmailSl No:12543* For more participants please add another form.Until October 10, 2013From October 11 to November 10, 2013Register By Price INR * Savings Registration Date No.Of Attendees Total Amount18,00020,0002,0000Please fax the completed form to us at +91 080-25149544 Or Email a scanned copy to customersupport@globalcompliancepanel.comGlobalCompliancePanel Seminar Registration FormGlobalCompliancePanelINDIA SEMINAR PURCHASE REQUEST DOCUMENT1. Event: Validations and Resolving Problems Related to Them2. Scheduled Date: November 11th and 12th, 20133. Quantity:4. Payment Mode:5. Check / DD no:6. Check / DD Dated:Customer Information:Name:Company:Email:Direct Ph no:Billing Address:P.S: Check to be drawn in favor of NetZealous Services India Pvt. Ltd. Please mail the cheque to the below address.Mr. Nithyananda Bhat ( ),Finance ManagerGururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar, Bangalore - 560078 Karnataka, INDIA For any further information or clarifications kindly email us at customersupport@globalcompliancepanel.com or call us at +91 080 32014957.Registration to the event will be subject to the following terms and conditions:ConfirmationA letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled for the event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Please submit payment for the prevailing rate. Please be advised that if payment or written cancellation notice is not received by October 25th, 2013, your credit card will be charged the prevailing rate.Attendee substitutionIf you are unable to attend, substitutions can be made at any time, including on site at the prevailing rate. However it has to be confirmed in writing with proper identification of the substitute person you plan to send on your behalf.Refund PolicyA request for refund should be made in writing and faxed to +91 080-25149544 or emailed to customersupport@globalcompliancepanel.in latest by October 25th, 2013, to receive a full refund minus 25% processing fee. After that time, no refunds or credit requests will be approved. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them.Cancellation PolicyGlobalCompliancePanel reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be canceled, registrants will be notified by GlobalCompliancePanel in writing as soon as possible and will receive a full refund. GlobalCompliancePanel will not be responsible for airfare or other costs incurred due to cancellation.Photo ReleaseBy registering for the GlobalCompliancePanel seminar I authorize GlobalCompliancePanel the right to photograph me and to use the photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release GlobalCompliancePanel from all claims arising out of the use of the photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership.For more details, contact GlobalCompliancePanel at orcustomersupport@globalcompliancepanel.comPlease call : 080 32014957 / 080 32473691 / Toll free: 1800 425 9409Please fax the completed form to us at +91 080-25149544 Or Email a scanned copy to customersupport@globalcompliancepanel.com