FDA's new enforcement initiative - Strategic Software Validation Planning for Executives and Managers

This FDA software validation training will discuss how to approach strategic software validation planning so as to satisfy FDA by complying to new enforcement initiatives by FDA.

Who will Benefit:
This seminar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics, Biological manufacturers, and outside support staff. The staff members who will benefit include:
-VP-Quality
-Director-Software Quality
-Director-Quality
-Director-Validation
-Manager-Software Quality
-Manager-Validation
-IT/IS Managers
-Regulatory Affairs
-Legal / General Counsel
-CIO/CFO
-Legal Staff/Attorneys
-Audit/Inspection coordinators
internal auditors
-QA / QC managers, executives and personnel
-IT / IS managers and personnel
-Validation specialists
-Software quality reviewers
-Consultants

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.