Computer Software Assurance: Use industry standards to be efficient and compliant
Instructor:
David Nettleton
Product ID: 707008
- 24
- March 2025
Monday - 10:00 AM PT | 01:00 PM ET
Duration: 75 Min
Learning Objectives:
- Which data and systems are subject to Part 11 and Annex 11
- Computer Software Assurance impact on risk-based
- Impact of Electronic Systems… Clinical Investigations Q&A Guidance for Industry Oct 2024
- Avoid 483 and Warning Letters
- Requirements for local, SaaS, and cloud hosting
- Reduce validation resources by using easy to understand fill-in-the-blank validation documents
Areas Covered in the Webinar:
- What 21 CFR Part 11 means today
- Purpose of Part 11
- What does Part 11 mean?
- SOPs
- System features
- Infrastructure qualification
- Validation
- Hardware is qualified
- IQ/OQ/PQ
- GAMP categories
- No validation
- Software Validation (SV)
- Computer System Validation (CSV)
- Expansion for industry categories
- Qualification of software utilities
- Hybrid Validation
- Statistical Analysis Program Validation
- Medical Device Software Validation
- Evolution of COTS CSV
- Test-based
- Risk-based
- Validation
- Software Validation for vendors
- Computer System Validation for users
- Change control re-validation
- SaaS/Cloud hosting
- Responsibilities for software vendor and hosting provider
- Evaluation criteria
- Hosting requirements
- How to implement compliance
- Software inventory
- Validation models and templates
Who Will Benefit:
- GMP, GCP, GLP, regulatory professionals
- QA/QC
- IT
- Auditors
- Managers and directors
- Software vendors, hosting providers
Industries which will get benefit from this training include Pharmaceutical, Medical Device, Biologics, Food, Cosmetics, FDA regulated companies, Software vendors, SaaS providers, Data centers
Instructor Profile:
David Nettleton
FDA Compliance Specialist, ComputerSystemValidation
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, 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 260 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.
More Training By Experts
- GAMP® Validation Protocols for Efficient Documentation
- Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
- 10-Step Risk Based Computer System Validation for SaaS/Cloud/Local Hosting
- Use Risk Assessment to Reduce Validation Time for 21 CFR Part 11
- Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
