This 6-hour virtual seminar is an essential guide on 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 self-identify areas of non-compliance. A well-designed audit program can be an effective tool for self-identifying, understanding, communicating, and reducing quality and compliance risks. Those companies that cannot self-identify problems are doomed to be informed of problems by regulators or customers.
However, many companies conduct audits only because they are required to by regulation. Businesses often see internal audits 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.
This seminar will highlight tools and techniques used by the FDA to conduct inspections of medical device companies. This perspective is invaluable in helping to self-identify and fix problems before the FDA finds them.
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 to the company. Even worse, management is blind to the impact on product quality and risk to the customer. This seminar will highlight red flags and ways to reduce compliance and quality risk.
However, many companies conduct audits only because they are required to by regulation. Businesses often see internal audits 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
- What we can learn from FDA inspection techniques
- How to apply FDA techniques to internal audit strategy
- How to develop and implement an efficient and effective audit program
- Red flags that your program is not effective
- Risk Analysis techniques
- Audit Program Structure
- The Auditing Process
Why you should attend
This seminar will highlight tools and techniques used by the FDA to conduct inspections of medical device companies. This perspective is invaluable in helping to self-identify and fix problems before the FDA finds them.
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 to the company. Even worse, management is blind to the impact on product quality and risk to the customer. This seminar will highlight red flags and ways to reduce compliance and quality risk.
Agenda
- Regulatory expectations for Internal Audit
- What can we learn from the FDA?
- Audit Program
- Audit Strategy
- The Auditing Process
- Preparation
- Planning
- Conducting
- Interviewing techniques
- Good documentation
- Following-up
- Monitoring progress
- Focus on Supplier Auditing
- Remote Audits
- Best Practices
Speakers
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 GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.Who Should Attend
- 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, Pharmaceutical, or Bio-tech companies
