Boston Professional Events List


Audit Like the FDA - What you need to know for a truly effective internal audit program


Date
May 04, 2017 - 09:00 AM - May 05, 06:00 PM
Organizer
GlobalCompliancePanel
Location
Embassy Suites By Hilton Boston,

Boston,
MA,
USA,
ZIP: 02128
Phone: 1 929 900 1853

This 2 day seminar will explore how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk.

However, estimates indicate that up to 75% of companies conduct audits only because they are required to by regulation. Businesses often see internal audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree. A well planned audit program can reduce these risks.

In this seminar, we will discuss:
  • Regulatory Expectations
  • How to develop and implement an efficient and effective audit program
  • Common problems
  • Red-flags that your program is not effective
  • Risk Analysis techniques
  • Audit Program Structure
  • The auditing process - steps and tools
  • Documentation and communication
  • Linkages within your Quality System to ensure audits lead to effective solutions and lasting improvement

Why should you attend:

Continuous Improvement starts with awareness of issues and opportunities. And without an effective audit program, management lacks awareness of the issues within their quality system. Management is blind to the gaps in the quality system and the risk that poses for the company. Even worse, management is blind to the impact on product quality and risk to the customer. This webinar will highlight red-flags and ways to reduce compliance and quality risk.

Learning Objectives:

Using lecture, interactive discussion, and exercises, this seminar will provide tools and techniques for you to develop or improve your audit program. Students will come away with key concepts, practice in these concepts, and extensive course notes for future use and reference. This 2-day seminar will cover the following areas:

  • Using a structured program to identify areas of risk leading to an effective audit strategy.
  • How to develop a meaningful structure of audit, oversight, transparent communication, and escalation to management review.
  • How to ensure your audit staff is well trained to proactively identify, communicate, and escalate issues.
  • How a culture of quality and compliance can encourage clear and transparent communication of risk.
  • How to prioritize, resource, and implement corrective actions.
  • Techniques for monitoring and communicating risk and improvement over time.
  • How to identify residual risk.
  • Signs that your company culture is taking unnecessary compliance or quality risk.
  • How to ensure management gets valuable information from your audit program.
  • Tools for documenting audit observations and managing corrective and preventive actions.
  • Roles and responsibilities.

Who will benefit:

  • Quality Systems Specialists
  • Document Control Specialists
  • Quality and Compliance Specialists
  • Auditors
  • Internal Auditors
  • Supplier Auditors
  • Auditor Managers
  • Supplier Auditors
  • CAPA Specialists
  • Quality/Compliance managers or directors for Medical Device companies
===
Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
- For event ticket, contact +1 929 900 1853
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
 
NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
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Agenda


Day 1 Schedule

Lecture 1:
Overview

Lecture 2:
Introductions

Lecture 3:
Regulatory expectations

Lecture 4:
Quality Systems requirements for medical devices

Lecture 5:
Types and goals of audits

Lecture 6:
Creating a program
Goals
Risk Analysis
Audit schedule
Oversight, communication, monitoring, and escalation

Lecture 7:
Linkages in your Quality System
CAPA
Metrics and monitoring
Management Review
What the FDA can look at
Record keeping and documentation

Lecture 8:
Auditor qualifications and skills
 
Day 2 Schedule

Lecture 1:
The auditing process
Preparation
Planning
Conducting
Interviewing techniques
Good documentation
Following-up
Monitoring progress

Lecture 2:
Focus on Supplier Auditing

Lecture 3:
Red Flags and Warning Signs

Lecture 4:
Best Practices
 


 


Speaker Details


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.


Event Categories
Keywords: fun, analysis, arts, business , communication , culture, design , Fun , implement, lear




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