Compliance Boot Camp 2017
- Start Date:
- Thursday, 23 March, 2017
- End Date:
- Friday, 24 March, 2017 6:00pm
- Pain Management, Psychiatry, Infectious Disease, Internal Medicine, Emergency Medicine, Pulmonary Medicine, Physical Medicine, Sports Medicine
Course "Compliance Boot Camp" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.Overview: This 2-day seminar will cover the essentials of compliance for medical device companies. An efficient and effective quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality.
This "Compliance Boot Camp" will get you started in setting up just such a Quality System. We'll discuss the "case for quality" and how you can use compliance, not as an end itself, but as a means to improved quality and reduced cost of non-compliance.In this seminar, we will discuss:Regulatory ExpectationsHow to plan, structure, and implement a quality systemCommon problems and lessons from 483 and warning lettersRed-flags that your QS is not effectiveAudit for self-awarenessRisk analysis and management techniquesCAPA, continuous improvement, and six sigmaPerformance monitoringCulture, Management Responsibility, and maturityKey Quality System elements and linkagesWhy should you attend? - This seminar will help you understand regulatory requirements and how to translate them into a quality system that is both effective and efficient.
You'll learn how to plan, structure, and implement a quality system specific for your business needs. We'll explore the capabilities that every medical device company needs to ensure quality products and a compliant quality system. We'll discuss how to create a quality strategy and plans. Will discuss methods to identify, prioritize, and analyze risks. Then will move on to continuous improvement, six sigma, and Corrective and Preventive Action to address issues within your Quality System.
You'll learn how to effectively communicate and escalate risk as well as monitor performance and progress.This seminar can help you get your quality system off to a good start and avoid common problems including MDRs, recalls, 483s, and warning letters!The expectations for quality and compliance continue to increase. We will discuss changing regulations and expectations and what you can do to prepare for them. This seminar will allow you to interact personally with an industry expert with over 30 years' experience in medical devices.
The instructor has worked in manufacturing, design, quality and compliance at industry leaders like GE, Johnson and Johnson, and Medtronic. She has traveled throughout the world developing, auditing, and improving quality systems.Learning Objectives:This 2-day seminar will cover the following areas:Quality System ExpectationsQuality System StructureStrategy and PlanningRisk management in your quality systemCase for QualityInspection preparedness and managementMonitoring and metricsCreating a quality strategy and plansWho will benefit:Quality Systems SpecialistsDocument Control SpecialistsQuality and Compliance SpecialistsAuditorsAuditor ManagersCompliance ManagersQuality ManagersCAPA SpecialistsQuality and Compliance directors for Medical Device companiesGeneral Managers and Executives wanting to use Compliance and Quality as a competitive strengthAgenda:Day 1 ScheduleLecture 1:OverviewLecture 2:IntroductionsLecture 3:Regulatory expectationsLecture 4:Quality Systems requirements for medical devicesLecture 5:Quality System structure and writing SOPsLecture 6:Roles and ResponsibilitiesLecture 7:Management Responsibility and a Culture of QualityLecture 8:Cost of QualityLecture 9:Key Capabilities for SuccessLecture 10:Metrics and performance monitoringLecture 11:Maturity ModelingDay 2 ScheduleLecture 1:An effective auditing program is a key to self-awarenessLecture 2:CAPA and root cause analysis - essentials for improvementLecture 3:Six Sigma for Quality and ComplianceLecture 4:Management ReviewLecture 5:Inspection preparedness and managementLecture 6:Red Flags and Warning SignsLecture 7:Best PracticesLecture 8:Risk Management for ComplianceLecture 9:Creating a strategy and quality planSpeaker: Susanne ManzQuality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc.
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at industry leaders like GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Worldwide Director of Design Quality, and Director of Corporate Compliance.
She has traveled extensively throughout the world conducting audits and helping companies to understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of NM.She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality.
She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance. Location: Washington, DC Date: March 23rd & 24th, 2017 and Time: 9:00 AM to 6:00 PM Venue: Courtyard Arlington Crystal City/Reagan National AirportAddress: 2899 Jefferson Davis Highway Arlington, VA 22202 USA Price: Price: $1,295.00 (Seminar Fee for One Delegate)Until February 15, Early Bird Price: $1,295.00 from February 16 to March 21, Regular Price: $1,495.00Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*Quick Contact:NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407Fax: 302-288-6884Email: firstname.lastname@example.org
Courtyard Arlington Crystal City/Reagan National Airport 2899 Jefferson Davis Highway Arlington,
Conference organized by NetZealous DBA as GlobalCompliancePanel
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