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: Boston, MA Date: November 16th & 17th, 2017 andTime: 9:00 AM to 6:00 PM

Venue: Embassy Suites Boston Logan Airport 207 Porter St, Boston, MA 02128, USA

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 14, Regular Price: $1,495.00

Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

Sponsorship Program benefits for “Quality Assurance Auditingfor 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.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com

support@globalcompliancepanel.com

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Phone: +1-510-584-9661

Website: http://www.globalcompliancepanel.com

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901152SEMINAR?eventbrite-November-2017-SEO

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