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Course "Audit like the FDA - What you need to know for a truly effective internal audit program" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
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
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:
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.
Quick Contact:
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Phone: 1-800-447-9407
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Website: http://www.globalcompliancepanel.com