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Complaint and Recall Management: A Compliant, Lean Program 2017

Start Date:
Thursday, 9 November, 2017
End Date:
Friday, 10 November, 2017 6:00pm
Speciality:
Neurology, Gastroenterology, Pain Management, Hepatology, Infectious Disease, Pediatrics, Internal Medicine, Emergency Medicine
Website:
http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901336SEMINAR?meetings4docs-November-2017-SEO

Course "Complaint and Recall Management: A Compliant, Lean Program" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications.

Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Attention will be paid to the application of risk management to a complaint handling system, and a specific risk management system explained. Learning Objectives: This seminar contains a streamlined review of the regulations, allowing the majority of time to be spent on a detailed focus on critical process requirements for compliance with the regulations.

Jeff will also call from his 30+ years of experience in this area to put forth recommendations for methods of documentation that are straightforward and compliant. Among these recommendations are contents of complaint records, root cause investigations, and corrective actions. This seminar also covers the application of risk management principles to complaint investigation Why you should attend: Complaint Handling is one of the more cross-functional aspects of your QMS, not to mention it being clearly the most customer-facing.

To that end, many different functions will benefit from this presentation:Customer Service (your "complaint taker")Regulatory personnelQuality Engineering personnelSales and Marketing personnelCustomer Service personnelR&D personnelManufacturing EngineeringExecutive ManagementConsultantsQuality system auditors Agenda: Day 1 Schedule Lecture 1:IntroductioLecture 2:Complaint HandlingRegulatory Overview: FDA, ISO 13485 (including 13485:2016)DefinitionsApplication of DefinitionsThe Value of "Non-complaints"Complaint Triage and HandlingComplaint Investigations"Closing" ComplaintsContents of Complaint FormComplaint Review and TrendingImplementation of Risk Management into Complaint HandlingCommon Pitfalls and How to Overcome ThemExercise: Complaint or Non-complaint? Day 2 Schedule Lecture 1:Adverse Event ReportingRegulatory Overview: FDA, MDDMDRsReporting ProcessReporting RequirementsVigilance ReportsReporting ProcessReporting RequirementsExercise: Reportability of EventsLecture 2:Recalls / Field Corrective ActionsRegulatory Overview: FDA, MEDDEV, Health CanadaFDA RegulationsEU RequirementsCompetent Authority Reportable EventReporting RequirementsCorrections and RemovalsMarket Withdrawal and Stock RecoveryRecall ClassificationsRoles and ResponsibilitiesLecture 3:Q&A - Conclusion SpeakerJeff KasoffDirector of Regulatory Affairs, Life-Tech, Inc Jeff Kasoff, RAC, CMQ/OE, LBB is the Principal Consultant at Lean to Quality, LLC.

He has more than 30 years of experience in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies.Jeff received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.

Location: Los Angeles Date: November 9th & 10th, 2017 and Time: 9:00 AM to 6:00 PMVenue: WILL BE ANNOUNCED SOON, Los Angeles Price: Price: $1,295.00 (Seminar Fee for One Delegate)Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register now and save $200. (Early Bird)Until September 30, Early Bird Price: $1,295.00 From October 01 to November 07, Regular Price: $1,495.00Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Sponsorship Program benefits for "Quality Assurance Auditing for FDA Regulated Industry" seminarAt this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO's of various designations.

Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry. As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts.

Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants. For More Information- https://www.globalcompliancepanel.com/control/sponsorship Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable{mso-style-name:"Table Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:10.0pt;mso-para-margin-left:0in;line-height:115%;mso-pagination:widow-orphan;font-size:11.0pt;font-family:"Calibri",sans-serif;mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;}

Organizer Details

Conference organized by NetZealous DBA as GlobalCompliancePanel

Address:
NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
Phone:
Event Manager
Email:
john.robinson@globalcompliancepanel.com

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