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Compliance Boot Camp 2017 Boston

Thu, November 16 - Fri, November 17, 2017 Boston, Massachusetts
Embassy Suites by Hilton Boston at Logan Airport 207 Porter St Boston, Massachusetts 02128 United States +1 617-567-5000

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About Compliance Boot Camp 2017 Boston

COMPLIANCE BOOT CAMP, BOSTON, NOVEMBER 16-17, 2017

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.

This event will take place at Embassy Suites by Hilton Boston at Logan Airport, 207 Porter St, Boston, Massachusetts.

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

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

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.

About Compliance Boot Camp 2017 San Diego

COMPLIANCE BOOT CAMP, SAN DIEGO, OCTOBER 26-27, 2017

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

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

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.

About Compliance Boot Camp 2017 San Diego

COMPLIANCE BOOT CAMP, SAN DIEGO, SEPTEMBER 14-15, 2017

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

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

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.

About Compliance Boot Camp 2017

Compliance Boot Camp, January 26-27, 2017:

What is this event?

Compliance Boot Camp seminar is for medical device companies and it will focus on an efficient and effective quality system which can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality.

This seminar will help to understand regulatory requirements and how to translate them into a quality system that is both effective and efficient.

The event will discuss about 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.

Where is this event located?

This event will take place at Hilton Garden Inn Phoenix Midtown, 4000 N Central Ave, Phoenix, Arizona, USA.

Who should attend this event?

This event is designed for Quality Systems Specialists, Document Control Specialists, Auditors, Compliance Managers, CAPA Specialists, Quality and Compliance directors for Medical Device companies.

What are some highlights of this event?

Organization will examine the capabilities that every medical device company needs to ensure quality products and a compliant quality system.

Event Highlights:

  • Regulatory expectations
  • Quality Systems requirements for medical devices
  • Quality System structure and writing sops
  • Management Responsibility and a Culture of Quality
  • Metrics and performance monitoring
  • An effective auditing program is a key to self-awareness
  • CAPA and root cause analysis - essentials for improvement
  • Six sigma for quality and compliance
  • Creating a strategy and quality plan

Speaker:

      Susanne Manz

Why should I attend this event?

  • Attendee will learn how to plan, structure and implement a quality system specific for your business needs.
  • Get opportunity to interact personally with an industry expert with over 30 years' experience in medical devices.

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