2014 - How Create a Value-Added cGMP & ISO 13485 Internal Auditing System

Instructor: Betty Lane
Description:
Internal audits are required by both the FDA and ISO 13485. This webinar will cover creating of a Risk-based an internal auditing program for compliance to FDA and ISO 13485 internal auditing requirements.
It will include how to set up and manage the auditing system, as well as an overview of how to conduct an internal audit, and document the results. It will discuss the value of a good internal auditing program in reducing compliance risk of all types.
This seminar will cover how to create a Risk-based, value-added internal auditing system including how to plan a realistic annual internal audit schedule that covers all the requirements of your company’s quality system. This seminar will explain how the principles of risk are incorporated into your audit program without adding a lot of additional audits, thus reducing your risk of non-compliance.
This webinar will provide the information you need to know to:
Develop or update a risk-based internal auditing system that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485
Manage an Internal Audit system
Understand the difference between internal and external audits
Learn how the internal auditing system can add value to your quality system and your company
Understand what makes a good internal audit
Understand the skill required for an internal auditor
Understand what the FDA must see to verify that you are conducting your internal audits as required
Why Should you Attend:
Does your current auditing program assure that you are efficiently meeting all FDA quality and regulatory requirements, such as labeling and premarket clearance? Does it assure that you are meeting all European and Canadian requirements, if you sell products in those areas? If not or if you do not know, this seminar will explain how these are incorporated into your audit program without adding a lot of additional audits, thus reducing your risk of non-compliance. By using a risk-based approach to you auditing program, you can focus on those areas where you are most at risk, but still cover all your auditing requirements.
Objectives of the Presentation:
Learn How to develop or streamline and internal auditing system based on the principles of risk management but is still compliant to FDA cGMP/ Quality System Regulation and ISO 13485
Know the difference between internal and external audits
Understand what skills are required for an internal auditor
Learn how the internal auditing system can add value to your quality system and your company
Understand what the FDA must see to verify that you are conducting your internal audits as required
Who can Benefit:
Audit Managers
Prospective Audit Managers
Current Internal Auditors
Prospective Internal Auditors
Quality Management
Regulatory Compliance Managers
Supplier Auditors
Quality Engineering
Register Now:
http://www.onlinecompliancepanel.com/ecommerce/web...