Effective Complaint Handling - Phoenix AZ

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:Effective Complaint Handling,Medical Device Reporting and Recalls By: David R. Dills, Regulatory Affairs & Compliance Consultant, Location : Singapore | March 20-21, 2014GlobalCompliancePanelCourse "Effective Complaint Handling, Medical Device Reporting and Recalls" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recerti?cation upon full completion. www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.David R. Dills, Regulatory Affairs & Compliance Consultant2-day In-person Seminar 2014David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.Day One - March 20, 2014 Day Two - March 21, 2014Course Outline:GlobalCompliancePanelLecture 1: Complaint Handling:? What are the elements of an effective complaint management ? system?? How does risk management in?uence complaint handling? decisions?? What are the responsibilities of other departments?? What is the best way to train customer contact employees?? What steps would the FDA expect to see the departments taking that sorts out potential? MDRs, product complaints and other reportable events?? What and how do you perform trending?? What are examples of how companies trend and analyze service calls and product complaints?? Understand how and why CAPA is tied in to product complaint investigation? What is an appropriate complaint handling system in a risk-based post-market environment?? How do you audit a complaint handling system?? From your audits, how do you judge that your complaint handling system is effective?? Assignment of responsibility? Manufacturer should develop a method for maintaining records of complaints and investigations that: is functional and economical, meets company needs, and meets FDA requirements and expectations? Identify designated complaint handling unit? Instructions for documenting complaint information? Process for evaluating complaints? Process for investigating complaints? Identify and process MDR's? How to process customer returns? Records and trend analysis? Complaint closure? Examples of tools currently being used to conduct investigations? How far and in-depth do you go with your investigations? What are current FDA "hot" buttons and trends, benchmarks and best practices for investigations? How to become a "good" investigator and the emphasis on closed-loop investigations? Written Procedures: Designated Complaint Handling Unit, Training and Records? Recent Enforcement ActionsLecture 2: Medical Device Reporting? Introduction to Medical Device Reporting? What are the key terms, de?nitions and forms?? MDR procedures and processes? What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?? How do you manage international reporting requirements under your complaint handling system?? Consider the relationship between MDRs and Risk AssessmentsLecture 2: Exercise and Recap of Day 1? Exercise on Product Complaints/Complaint Handling? QuizLecture 4: Medical Device Reporting? eMDR Electronic Medical Device Reporting? How to Report a Problem? Event Problem Codes and Manufacturer Evaluation Codes? MedWatch: Safety Information and AER Program? Completing Form FDA 3500A? What form should I use to submit reports of individual adverse events and where do I obtain these forms? ? Where and how do I submit reports and additional information? ? Does the information in my report constitute an admission that the device caused or contributed to the reportable event?? What are the requirements for developing, maintaining, and implementing written MDR procedures and maintain records/?les that apply to me?? Requirements for Individual Adverse Event Reports? User Facility Reporting, Importer Reporting and Manufacturer Reporting RequirementsLecture 5: Recalls? What happens in a medical device recall: Firm-initiated recall vs. mandatory recall? What information needs to be reported?? What types of records do companies need to keep?? Prior to notifying FDA, what steps should you have taken?? What are the dos and don'ts when informing FDA of a product problem?? Who should be involved in the decision process?? Who should be responsible for communicating with FDA?? What are the consequences of a recall?? What factors should you consider when determining whether or not to get your product back?? How do you prepare for a post recall inspection?? What customer and other outside communications are necessary?? What documentation should be prepared?? How should the product liability implications of recall communications be handled?? What is an effectiveness check?? Health Hazard Evaluations are conducted by FDA? How should you write your recall correspondence?? How do you determine that your recall is completed and what do you do to close your recall internally and with FDA?? Create and use a recall operational ? Understand what is required for the recall strategy as expected by FDA? Depth of recall and using a viable, sustainable and effective strategy? Understand why the documentation and paper trail are so critical and termination of a recall ? Discuss most recent recalls not only for devices but pharmaceuticals and why the numbers are alarmingLecture 6: Exercise and Recap of Day 2? Exercise - MDR and Recall? Quizwww.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.2-day In-person Seminar 2014Register now and save . (Early Bird)$200Until February 28, Early Bird Price: $1,595.00From March 01 to March 18, Regular Price: $1,795.00March 20-21, 2014 | Singapore**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.Price for One Delegate pass Price: $1,595.00Pricing 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:? Regulatory Affairs Management? Regulatory Affairs Specialist? Auditors? Compliance Officer? Compliance Specialist? Clinical Affairs? Quality Assurance ManagementWho Will Benefit:? Marketing & Sales? Distributors/Authorized Representatives? Legal Counsel? Engineering/Technical Services? Operations/Manufacturing? ConsultantsContact Information: Event CoordinatorToll free: 1800 447 9407 Fax: 302 288 6884Email: support@globalcompliancepanel.comSingapore Contact: +65-3158-3448NetZealous 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 GlobalCompliancePanelGlobalCompliancePanelwww.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 on +1-800-447-9407Call us on or fax your PO to 302 288 6884+1-800-447-9407Please 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 +1-800-447-9407 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, USASingapore Contact: +65-3158-3448Toll free (US): +1-800-447-9407 / Fax (US): 302 288 68842-day In-person Seminar 2014GlobalCompliancePanel