The 6 Most Common Problems in Computer System Assurance and Validation

Webinar Details

Speaker

David Nettleton

Industry

Pharmaceuticals

Speciality

Pharmaceuticals

Available

All Days

Duration

120 Minutes


Registration Options

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Description

This webinar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means increased exposure.  Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. Corporate uncertainty leads to inaction and “wheel spinning.” Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards.

This webinar covers the fundamentals of 21 CFR Part 11, software validation, and computer system validation. It provides details for company compliance including GAMP, qualification, and validation. It teaches the Part 11 industry standards for SOPs, security, data transfer, audit trails, and electronic signatures. The webinar details the common problems and how to avoid them.

Learning Objectives

  • Which data and systems are subject to 21 CFR Part 11 and Annex 11
  • Why data integrity compliance makes good business sense.
  • Requirements for local, SaaS, and cloud hosting
  • The 6 Most Common Problems in FDA Software Validation & Verification.
  • Strategies on how to avoid the most common problems.
  • Advice on successful validation project staffing.
  • Learn how to avoid 483 and Warning Letters
  • Which software needs validation and which does not
  • Understand GAMP, qualification, and validation
  • Learn what the regulations mean, not just what they say
  • Examine the regulatory requirements for the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation.
  • Understand the current computer system industry standards for security, data transfer, audit trails, and electronic signatures.

Why Should You Attend

Avoid the 6 most common problems associated with Part 11 and Annex 11 compliance. Learn how to efficiently create the specific documents required to implement data integrity requirements.

Who Should Attend

  • System owners - responsible for keeping individual systems in validation
  • Computer system users
  • QA / QC managers, executives, and personnel
  • IT / IS managers and personnel
  • Validation specialists
  • Laboratory staff
  • Managers
  • GMP, GCP, and GLP professionals.
David Nettleton
David Nettleton

(speaker)

Computer System Validation’s principal, David Nettleton, is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Data Protection Regulation (GDPR), software validation, and computer system validation. He is involved with developing, purchasing, installing, operating, and maintaining computerized systems used in FDA-compliant applications. He has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. His most recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates for completing a COTS software validation project.

Registration Options

Choose Your Options

Error Conference Exists In Wish-list.

Congrats Conference Added In Wish-list.


Need Corporate Discount ?


  • * For more than 6 attendee call us at +1-800-803-7592 or mail us at cs@conferencepanel.com
  • * For Check and ACH payment call us at +1-800-803-7592 or mail us at cs@conferencepanel.com
  • * Click to download the Order Form
David Nettleton
David Nettleton

(speaker)

Computer System Validation’s principal, David Nettleton, is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Data Protection Regulation (GDPR), software validation, and computer system validation. He is involved with developing, purchasing, installing, operating, and maintaining computerized systems used in FDA-compliant applications. He has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. His most recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates for completing a COTS software validation project.