How to successfully audit software systems, and thereby avoid having FDA write software-related 483's and warning letters

Instructor: Dennis Moore
Product ID: 700221
Training Level: Intermediate
  • 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
Last Recorded Date: May-2010

Training CD / USB Drive

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

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Read Frequently Asked Questions

This Software Auditing Procedure training will discussion on FDA software Standard “General Principles of Software Validation”, Actual FDA investigator software auditing techniques for software failure investigations.

Why Should You Attend:
Many companies are confident that their software system is compliant to the Quality System Regulation, yet FDA conducts an inspection and FDA 483 software related cites are written and warning Letters, seizures or worse ensue. This presentation will review the FDA Software Standard “General Principles of Software Validation". Understanding this guidance is vital for compliance and for regulatory submission success. We will address Real auditing processes and risk management tools relative to this standard. The process that FDA investigators use relative to software failure investigations will also be discussed. Real auditing processes and risk management tools will be discussed.

Learning Objectives:

  • What FDA expects and will request from you during your software review.
  • Learn how QSIT inspections related to software systems and its attendant record keeping are performed by FDA.
  • Learn how change control issues affect software records.
  • Learn what constitutes a good software auditing procedure.
  • Learn how do how to counteract a possible FDA 483 cite.
  • How risk management fits into software compliance.
  • Learn how to incorporate the FDA “General Principles of Software Validation" document into your quality system.
Areas Covered in the Seminar:
  • Introduction.
  • Guidance documents/ QS regulation.
  • Major FDA 483 points.
  • Trends in FDA warning letters.
  • Determining best practice for the software audit.
  • Conducting a MORE thorough audit.
  • FDA 483 point issuance prevention.
  • Questions & Answers.

Who Will Benefit:

The following individuals or disciplines will benefit from attending this Webinar:
  • Senior executives of pharmaceutical and device firms
  • Quality Unit Vice Presidents, Directors and Managers
  • Vice presidents, Directors and Managers of operations
  • Quality engineers and field auditors
  • Regulatory and Compliance Management
  • Consultants
  • Quality System Auditors

Instructor Profile:
Dennis M. Moore, is the President CEO and Founder of AUK Technical Services LTD (ATS). a worldwide consulting firm which specializes in Quality Systems and submissions for medical device and pharmaceutical companies. Mr. Moore is a former 22 year FDA credentialed Government investigator, Retired Peace Officer and author of many articles on quality system concepts. Mr. Moore has performed hundreds of FDA device and drug inspections, and written many FDA 483 and warning letter citations. He also has industry experience on the manufacturer side of the auditing desk.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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