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Complaint handling-management-cape-town

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GlobalCompliancePanel
GlobalCompliancePanel

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

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2-day In-person Seminar: Knowledge, a Way Forward… Complaint Handling and Management: From Receipt to Trending Cape Town, SA July 25th and 26th, 2016 9:00 AM to 6:00 PM David Dills Regulatory Affairs & Compliance Consultant, David 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. An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution. Overview : Global CompliancePanel (Without Stay) Price: $1,695.00 (Seminar for One Delegate) (With Stay) Price: $2,095.00 (Seminar for One Delegate) Register now and save $200. (Early Bird) **Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar. Price Seminar Pricing Includes (With Stay) 2 Days Stay Pick-up and Drop Facility (Nearest Airport) Break-Fast and Lunch High Tea Pack of 3 Webinars will be provided which has been done in the past on similar subject Register for 5 attendees (With stay) Price: $7,333.00 $1,0475.00 You Save: $3,142.5 (30%)*
2-day In-person Seminar: Complaint Handling and Management: From Receipt to Trending Global CompliancePanel Agenda: Day One Day Two Lecture 1 : Complaint Handling:  How does risk management influence 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 Actions Lecture 1 : Medical Device Reporting  MDR 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/files that apply to me?  Requirements for Individual Adverse Event Reports  User Facility Reporting, Importer Reporting and Manufacturer Reporting Requirements Lecture 2 : 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?
2-day In-person Seminar: Complaint Handling and Management: From Receipt to Trending Global CompliancePanel Agenda: Day One Day Two Lecture 2 : Medical Device Reporting  Introduction to Medical Device Reporting  What are the key terms, definitions 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 Assessments Lecture 3 : Exercise and Recap of Day 1  Exercise on Product Complaints/Complaint Handling  Quiz  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 alarming Lecture 3 : Exercise and Recap of Day 2  Exercise - MDR and Recall  Quiz Areas Covered in the Session:  Areas of special concentration will include:  Reporting complaints  Managers  Complaint evaluation and investigation  Data collection and trending  CAPA process for investigating complaints  Accelerate complaints recording, investigation, reporting, escalation/triggers and closure cycle as cases are automatically routed from one stage to the next  Gain enterprise-wide visibility into the complaints data and track the process with performance metrics, dashboards or other indicators  Improve communication and teamwork on complaints across departments and functional areas  Drive continuous improvement by tying corrective actions with complaints for a closed loop quality process  Improve management of the complaint lifecycle with real-time trending and escalation of customer complaints  Understand the History of MDR Regulation Who Will Benefit:  Understand that although FDA does not specify a standard complaint handling system, the requirements do specify certain actions that shall be included in any system  Grasp and comprehend the definitions and elements of the regulatory requirements for Complaint Handling, Medical Device Reporting and handling of Recalls  All personnel who deal with customers, or who may receive a complaint call, must be trained in the proper routing/handling of complaints  Provide information about FDA's Medical Device Reporting (MDR) regulation and the Voluntary Reporting program called MedWatch  Introduce you Medical Device Reporting and to help you better understand the process and benefits of Voluntary Reporting and responsibilities  Latest Amendments to the MDR Regulation to Implement FDAMA Changes  To Recall or Not to Recall: Issues to consider regarding whether a Field Action is required
Global CompliancePanel www.globalcompliancepanel.com Kindly get in touch with us for any help or information. Look forward to meeting you at the seminar GlobalCompliancePanel What You will get Special price on future seminars by GlobalCompliancePanel. Networking with industry's top notch professionals 7 9 1 Learning Objectives 2 Participation certificates Interactive sessions with the US expert Post event email assistance to your queries. Special price on future purchase of web based trainings. Special price on future consulting or expertise services. 3 4 5 6 Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog, notepad and pen. 8 Contact Information: Event Coordinator NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Toll free: +1-800-447-9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com 10% 20% 25% 30% 2 Attendees to get offer 3 to 6 Attendees to get offer 7 to 10 Attendees to get offer 10+ Attendees to get offer Group Participation Payment Option 1 Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link 2 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 +1-800-447-9407 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 +1-800-447-9407 for the wire transfer information 3 4 2-day In-person Seminar: Complaint Handling and Management: From Receipt to Trending

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Complaint handling-management-cape-town

  • 1. 2-day In-person Seminar: Knowledge, a Way Forward… Complaint Handling and Management: From Receipt to Trending Cape Town, SA July 25th and 26th, 2016 9:00 AM to 6:00 PM David Dills Regulatory Affairs & Compliance Consultant, David 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. An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution. Overview : Global CompliancePanel (Without Stay) Price: $1,695.00 (Seminar for One Delegate) (With Stay) Price: $2,095.00 (Seminar for One Delegate) Register now and save $200. (Early Bird) **Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar. Price Seminar Pricing Includes (With Stay) 2 Days Stay Pick-up and Drop Facility (Nearest Airport) Break-Fast and Lunch High Tea Pack of 3 Webinars will be provided which has been done in the past on similar subject Register for 5 attendees (With stay) Price: $7,333.00 $1,0475.00 You Save: $3,142.5 (30%)*
  • 2. 2-day In-person Seminar: Complaint Handling and Management: From Receipt to Trending Global CompliancePanel Agenda: Day One Day Two Lecture 1 : Complaint Handling:  How does risk management influence 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 Actions Lecture 1 : Medical Device Reporting  MDR 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/files that apply to me?  Requirements for Individual Adverse Event Reports  User Facility Reporting, Importer Reporting and Manufacturer Reporting Requirements Lecture 2 : 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?
  • 3. 2-day In-person Seminar: Complaint Handling and Management: From Receipt to Trending Global CompliancePanel Agenda: Day One Day Two Lecture 2 : Medical Device Reporting  Introduction to Medical Device Reporting  What are the key terms, definitions 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 Assessments Lecture 3 : Exercise and Recap of Day 1  Exercise on Product Complaints/Complaint Handling  Quiz  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 alarming Lecture 3 : Exercise and Recap of Day 2  Exercise - MDR and Recall  Quiz Areas Covered in the Session:  Areas of special concentration will include:  Reporting complaints  Managers  Complaint evaluation and investigation  Data collection and trending  CAPA process for investigating complaints  Accelerate complaints recording, investigation, reporting, escalation/triggers and closure cycle as cases are automatically routed from one stage to the next  Gain enterprise-wide visibility into the complaints data and track the process with performance metrics, dashboards or other indicators  Improve communication and teamwork on complaints across departments and functional areas  Drive continuous improvement by tying corrective actions with complaints for a closed loop quality process  Improve management of the complaint lifecycle with real-time trending and escalation of customer complaints  Understand the History of MDR Regulation Who Will Benefit:  Understand that although FDA does not specify a standard complaint handling system, the requirements do specify certain actions that shall be included in any system  Grasp and comprehend the definitions and elements of the regulatory requirements for Complaint Handling, Medical Device Reporting and handling of Recalls  All personnel who deal with customers, or who may receive a complaint call, must be trained in the proper routing/handling of complaints  Provide information about FDA's Medical Device Reporting (MDR) regulation and the Voluntary Reporting program called MedWatch  Introduce you Medical Device Reporting and to help you better understand the process and benefits of Voluntary Reporting and responsibilities  Latest Amendments to the MDR Regulation to Implement FDAMA Changes  To Recall or Not to Recall: Issues to consider regarding whether a Field Action is required
  • 4. Global CompliancePanel www.globalcompliancepanel.com Kindly get in touch with us for any help or information. Look forward to meeting you at the seminar GlobalCompliancePanel What You will get Special price on future seminars by GlobalCompliancePanel. Networking with industry's top notch professionals 7 9 1 Learning Objectives 2 Participation certificates Interactive sessions with the US expert Post event email assistance to your queries. Special price on future purchase of web based trainings. Special price on future consulting or expertise services. 3 4 5 6 Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog, notepad and pen. 8 Contact Information: Event Coordinator NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Toll free: +1-800-447-9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com 10% 20% 25% 30% 2 Attendees to get offer 3 to 6 Attendees to get offer 7 to 10 Attendees to get offer 10+ Attendees to get offer Group Participation Payment Option 1 Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link 2 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 +1-800-447-9407 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 +1-800-447-9407 for the wire transfer information 3 4 2-day In-person Seminar: Complaint Handling and Management: From Receipt to Trending