FDA Software Validation Self-Check – plan an effective Internal Audit program

This FDA software validation Webinar/training will discuss how to self audit and ensure validation and software quality processes that will pass FDA inspection.
Why Should You Attend:
FDA Commissioner Margaret Hamburg recently announced several new enforcement initiatives. They are certain to impact your regulatory risk profile. How will you prepare for software quality, software validation and 21 CFR part 11 planning?
Pharma, Biotech and Medical Device manufacturers are self-regulated with FDA oversight. By the time FDA come to your door, it may be too late to bring order to chaos. Companies have the responsibility to self audit to ensure compliance to GMP regulations. FDA inspectors are trained to know what to look for - you should too! Internal audits can be used for process improvement and leaning. Regular and diligent internal audits will help immunize you against severe penalties. Learn how to protect your internal audit records from FDA inspection.
Areas Covered in the seminar:

Outline of FDA regulations as applied to software.
Review of FDA software validation requirements.
FDA inspection process.
How to 'design to succeed'.
Inspection preparation.
Documentation review.
Internal behavior review.

Internal auditors
External auditors
Supplier auditors
Quality Assurance personnel and management
SQA - Software Quality personnel
Consultants
Business managers responsible for system compliance
IT / IS managers
Regulatory affairs personnel and management

At ComplianceOnline, we are focused on :
Enhancing global compliance, creating a world where quality and compliance professionals, regulators,and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

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