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Audit Like the FDA - Effective Internal Audit Program

2-Day Seminar Completed | Recording and Pre-Registration Available

$1200 
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PRE-REGISTRATION AVAILABLE 

If you want to have this training scheduled Live and Exclusively for your company, we will arrange it for you.

Pre-Register now and pay only once the training is scheduled on your preferred days.



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

SEMINAR OBJECTIVES
WHO SHOULD ATTEND

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

AGENDA

DAY 1 (10 AM to 2 PM)

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


DAY 2 (10 AM to 2 PM)

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



COURSE DIRECTOR: SUSANNE MANZ

Susanne Manz 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. She 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 Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.