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

Why Should You Attend:

FDA has in place several 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?

Extensive use of automated manufacturing, laboratory, QA, QC, complaints, CAPA, Adverse Events systems puts companies at risk. FDA field staff has been trained on software validation and 21 CFR Part 11 inspection and enforcement. Many companies have fallen behind in their software validation practices. Now is the time for forward planning in this crucial area. This executive planning session discusses the key elements on which to focus. The attendee should leave this strategic planning session confident in knowing how FDA will approach software validation enforcement and how to prevent needless inspections, as well as how to satisfy an FDA inspector.

Areas Covered in the Seminar:

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

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.