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

Instructor: Alfonso Fuller
Product ID: 701456
Training Level: Advanced
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

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.

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
  • 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.

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