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

The session covers the fundamentals of 21 CFR Part 11, software validation, and computer system validation, and 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, and details the common problems and how to avoid them.

Attendees learn how to efficiently create the specific documents required to implement data integrity requirements, which data and systems are subject to Part 11 and Annex 11, requirements for local, SaaS, and cloud hosting, and how to avoid 483s and Warning Letters. The course also clarifies which software needs validation and which does not, and explains what the regulations mean — not just what they say. Attendees receive presentation materials.

Webinar takeaway:

• 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 and verification
• Strategies on how to avoid the most common problems
• Advice on successful validation project staffing
• How to avoid 483s and Warning Letters
• Which software needs validation and which does not; understanding GAMP, qualification, and validation

After this webinar, attendees will be able to answer -

• What are the six most common problems in FDA software validation and verification?
• Which data and systems fall under 21 CFR Part 11 and Annex 11?
• What are the Part 11 industry standards for SOPs, security, data transfer, audit trails, and signatures?
• What documentation is required to implement data integrity, and how do local, SaaS, and cloud hosting differ?
• Which software needs validation and which does not, and how do GAMP, qualification, and validation fit together?
• How can companies avoid 483s and Warning Letters and staff a validation project successfully?

This webinar benefits the following agencies -

The session is built around U.S. FDA software and computer system validation expectations and references 21 CFR Part 11 and EU Annex 11, along with GAMP. It is relevant to organizations validating software in FDA-regulated pharmaceutical, medical device, and biologics environments.

Who should attend?

This webinar benefits the following roles:

• 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