Validation and use of Access Databases in FDA regulated environments

Instructor: Alfonso Fuller
Product ID: 701640
Training Level: Intermediate
  • Duration: 60 Min

recorded version

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In this FDA Regulated training learn regulation as applied to access database and how to validate with FDA requirements.

Course "Validation and use of Access Databases in FDA regulated environments" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend :

FDA expressly regulates databases and FDA inspectors are specifically trained to look for and at databases. Though database use is widespread throughout most organizations, most organizations lack a clear compliance strategy for 'small' databases. Many companies struggle with Access database compliance. Some are still using unvalidated databases. Hence an unplanned 'emergency' Access database validation project could paralyze the organization. Many companies lack an understanding of how to satisfy FDA technical validation requirements as applied to Access.

This seminar will describe methods for planning and executing Access validations that satisfy FDA requirements. Learn common technical issues with access database and how to resolve them.

Areas Covered in the Seminar:

  • Outline of FDA regulations as applied to software in general.
  • Review of FDA software validation requirements as applied to Access databases.
  • What's in it for you to validate Access databases.
  • Common technical issues with Access databases.
  • Common resolutions to technical issues.
  • Review of Access database usage in FDA regulated environments.

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:
  • System owners and personnel who create or use Access databases in FDA regulated areas
  • 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, LLC, 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 numerous white papers, has spoken at lots of 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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