$1,295.00

Compliance Boot Camp 2017

18 Compliance Boot Camp

Description

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. Susa

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