ADVOCATE. CONNECT. INNOVATE.

FDA Audit – An Essential Tool for Continuous Improvement

Plano, TX

4/25/2017

10:00 am - 1:00 pm

Description:
This webinar will explore how to improve your internal audit program so it is the efficient and effective tool it is meant to be. 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 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.

In this webinar, we will discuss:
• Identify red-flags that your program is not effective
• Identify weaknesses in your internal audit program
• Risk Analysis techniques
• Audit Program Structure
• Improvements for your Audit Program

Why should you attend:
Continuous Improvement starts with awareness of issues and opportunities. And without an effective internal 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 reduce compliance and quality risk.

Learning Objectives:
• Changing regulations and the case for Quality
• How quality can be seen as a competitive strength
• Cost of Quality and impact to business success
• Developing a Culture of Quality

Areas Covered in the Session:
• 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.
• Tools for monitoring and communicating risk and improvement over time.
• How to identify residual risk.
• Monitoring and Controlling progress over time.
• Signs that your company culture is taking unnecessary compliance or quality risk.
• How to ensure management gets valuable information from your audit program.
• How to prioritize, resource, and implement corrective actions.
• Tools for monitoring and communicating risk and improvement over time.

Who will benefit: (Titles)
• Quality Systems Specialists
• Document Control Specialists
• Quality and Compliance Specialists
• Internal Auditors and Managers
• Training Specialists
• CAPA Specialists
• Quality/Compliance managers or directors for Medical Device companies
• General Managers wanting to learn how to Management Review and expectations

Instructor Profile:
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 is a Presidential Scholar with 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. For more information, visit www.ManzConsultingInc.net.

For More information
Email: david@grcts.com | Web: www.grcts.com | Tel:+1-248-233-2049

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Contact: David
Contact Phone: 2482332049
Contact Email: david@grcts.com

Event Address:

GRC Training Solutions
#4512 LEGACY DR STE 100,
PLANO,Texas,
United States – 75024.
Email: support@grcts.com
Tel: +1-248-233-2049