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2-day In-person Seminar

Compliance Boot Camp


March 23rd & 24th, 2017

Time: 9:00 AM to 6:00 PM

Washington, DC

Venue: Courtyard Arlington Crystal City/Reagan National Airport


Director : Susanne Manz
  Price: $1,495.00
(Seminar Fee for One Delegate)

  Register for 5 attendees   Price: $4,485.00
      $7,475.00 You Save: $2,990.00 (40%)*

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

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.

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

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

Want to register by P.O/Check?
We facilitate registration by P.O/Checks!
Complete your registration in just a few easy steps
Please just download, fill out the registration form and send it to us either by email to support@globalcompliancepanel.com or just fax us at 302 288 6884.
Once the form is received, an invoice will be generated and sent back to your fax number.
Following this just send us your purchase order by fax at 302 288 6884
Click here to download Registration form
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In case you wish to register by using check, please make a check to NetZealous LLC DBA GlobalCompliancePanel.com and mail it to the below address.
NetZealous LLC,
DBA GlobalCompliancePanel,
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
Phone: 1800 447 9407

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Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

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: Washington, DC Hotel: Courtyard Arlington Crystal City/Reagan National Airport   2899 Jefferson Davis Highway Arlington, VA 22202 USA

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