FDA`s new enforcement initiative – Strategic Software Validation Planning for Executives and Managers 2013

FDA`s new enforcement initiative Strategic Software Validation Planning for Executives and Managers 2013 is a webinar that covers topics such as:

• When will FDA issue a Warning Letter for software validation
• Outline of new FDA enforcement approach
• How planning can help now and in the future
• What happens after a Warning Letter is issued under the new enforcement system?
• How your people can really help or hurt you
• The pivotal role of the Director of Software Quality / Software Validation
• Effective software quality / validation structure

Who should Attend

Director-Software Quality, VP-Quality, Director-Validation, Director-Quality, Manager-Validation, Manager-Software Quality, Regulatory Affairs, IT/IS Managers, CIO/CFO, Legal / General Counsel, Audit/Inspection coordinators, Legal Staff/Attorneys, QA / QC managers, executives and personnel, internal auditors, Validation specialists, IT / IS managers and personnel, Consultants and Software quality reviewers.