RAPS - This course has been pre-approved by RAPS as eligible for up to 2 credits towards a participant's RAC recertification upon full completion.
Overview
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.
Why Should You Attend
Avoid the 6 most common problem associated with Part 11 and Annex 11 compliance. Learn how to efficiently create the specific documents required to implement data integrity requirements.
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 & 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
Who Will Benefit
- 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, GLP professionals
David Nettleton (25 +yrs exp.)
Owner, Computer System Validation and FDA Compliance consultant
Sacramento, California Area
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 the development, purchase, installation, operation and maintenance of 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.
2.0 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 2 credits towards a participant's RAC recertification upon full completion.
World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria
