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

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.

Level the playing field by being prepared! Learn how to self-audit and ensure validation and software quality processes that will pass FDA scrutiny.Attendees should leave the seminar confident in being able to plan an effective internal audit program

Areas Covered in the Webinar:

• 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.

Who will benefit:

This seminar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. The staff members who will benefit include:

• 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

Instructor Profile:

Alfonso Fuller, is the founder and President of Fuller Compliance, a consulting firm that specializes in FDA quality system, software quality and software validation for pharmaceutical, biotech and medical device companies. Al is the author of several white papers, has spoken at numerous seminars, and has represented many clients before FDA compliance and enforcement personnel, and actively consults on day-to-day compliance issues.