Compliance Boot Camp 2017 - Compliance Boot Camp 2017

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 Expectations
• How to plan, structure, and implement a quality system
• Common problems and lessons from 483 and warning letters
• Red-flags that your QS is not effective
• Audit for self-awareness
• Risk analysis and management techniques
• CAPA, continuous improvement, and six sigma
• Performance monitoring
• Culture, Management Responsibility, and maturity
• Key Quality System elements and linkages
Why 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 Expectations
• Quality System Structure
• Strategy and Planning
• Risk management in your quality system
• Case for Quality
• Inspection preparedness and management
• Monitoring and metrics
• Creating a quality strategy and plans
Who will benefit:
• Quality Systems Specialists
• Document Control Specialists
• Quality and Compliance Specialists
• Auditors
• Auditor Managers
• Compliance Managers
• Quality Managers
• CAPA Specialists
• Quality and Compliance directors for Medical Device companies
• General Managers and Executives wanting to use Compliance and Quality as a competitive strength
Agenda:
Day 1 Schedule
Lecture 1:
Overview
Lecture 2:
Introductions
Lecture 3:
Regulatory expectations
Lecture 4:
Quality Systems requirements for medical devices
Lecture 5:
Quality System structure and writing SOPs
Lecture 6:
Roles and Responsibilities
Lecture 7:
Management Responsibility and a Culture of Quality
Lecture 8:
Cost of Quality
Lecture 9:
Key Capabilities for Success
Lecture 10:
Metrics and performance monitoring
Lecture 11:
Maturity Modeling
Day 2 Schedule
Lecture 1:
An effective auditing program is a key to self-awareness
Lecture 2:
CAPA and root cause analysis - essentials for improvement
Lecture 3:
Six Sigma for Quality and Compliance
Lecture 4:
Management Review
Lecture 5:
Inspection preparedness and management
Lecture 6:
Red Flags and Warning Signs
Lecture 7:
Best Practices
Lecture 8:
Risk Management for Compliance
Lecture 9:
Creating a strategy and quality plan
Speaker:
Susanne Manz
Quality 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: San Diego, CA Date: September 14th & 15th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: DoubleTree by Hilton San Diego Downtown 1646 Front St, San Diego, CA 92101, USA
Price:
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until August 10, Early Bird Price: $1,295.00 From August 11 to September 12, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar
At 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.
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