Dates: SEPTEMBER 12 - 13, 2022

Time (Eastern Time US): 10 AM to 2 PM
Time (Central Europe): 4 PM to 8 PM

Duration: 2 DAYS

Course Director: SUSANNE MANZ

As Various parts of the world are still battling the Coronavirus (COVID-19), we are conducting the class 100% online.
Audit Like the FDA - Effective Internal Audit Program

RESERVE YOUR SEAT TODAY!

Susanne Manz

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, 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.

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.


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.

WHAT WILL BE DISCUSSED:
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



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.


  • Quality/Compliance Directors, VP’s & Specialists for Medical Device companies
  • Quality Systems Specialists
  • Document Control Specialists
  • Auditors
  • Internal Auditors
  • Supplier Auditors
  • Auditor Managers
  • CAPA Specialists

10:00 AM - 02:00 PM
DAY 1

Lecture 1: Overview and Regulatory expectations

Lecture 2: Quality Systems requirements for medical devices

Lecture 3: The Audit Program
- Types and goals of audits
- Creating a program
- Goals
- Risk Analysis
- Audit schedule
- Oversight, communication, monitoring, and escalation

Lecture 4: Linkages in your Quality System
- CAPA
- Metrics and Monitoring
- Management Review
- What the FDA can look at
- Record keeping and documentation

Lecture 5: Auditor Qualifications and Skills

10:00 AM - 02:00 PM
DAY 2

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

Interactive Discussion and Exercises

2-Day Virtual Seminar on Audit Like the FDA - Effective Internal Audit Program

  • Date: 9/12/2022 10:00 AM
  • Location Online Event

Tickets


Ticket Type
Qty
1 Attendee - Live only
$1200.00
0
2 Attendees - Live only
$2200.00
0
3 Attendees - Live only
$3100.00
0
4-10 Attendees - Live only
$4900.00
0
Recording Only - Unlimited Viewers
$3900.00
0

Total

$0.00