Compliance Boot Camp - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "Compliance Boot Camp" conference to their offering.

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

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

Speakers:

Susanne Manz

President and Principal Consultant

Manz Consulting, Inc.

For more information about this conference visit http://www.researchandmarkets.com/research/5qbzz3/compliance_boot

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices