Software Validation: Avoiding FDA Warning Letters and Consent Decree
As one among the most leading causes for warning letters and consent decrees, software validation and its compliance are essential to keep your business ready for FDA audits and inspections.
Learn best practices to conform to FDA software validation requirements in this webinar with a leading FDA and regulatory affairs expert.
$425
$229
INSTRUCTOR PROFILE
Computer System Validation’s principal, David Nettleton, is an industry leader, author, and instructor on topics pertaining to 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 250 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.
Course Includes:
- Which data and systems are subject to Part 11 and Annex 11
- How to write a Data Privacy Statement
- What the regulations mean, not just what they say
- Avoid 483 and Warning Letters
- Requirements for local, SaaS, and cloud hosting
- Understand the current industry standard software features for security, data transfer, audit trails, and electronic signatures
- How to use electronic signatures, ensure data integrity, and protect intellectual property
- SOPs required for the IT infrastructure
- Product features to look for when purchasing COTS software
- Reduce validation resources by using easy to understand fill-in-the-blank validation documents
Limited Time Offer - Only $229!
Here is the Agenda
- What 21 CFR Part 11 means today
- Purpose of 21 CFR Part 11
- Security Standards: Roles, User Names and Restrictions
- Data transfer standards
- Audit trail standards
- Electronic approval standards
- Infrastructure qualificationList Item
- Validation
- SaaS/Cloud hosting
- SOPs
- Annex 11
- EU GDPR
Who Will Benefit
GMP, GCP, GLP, regulatory professionals
QA/QC
IT
Auditors
Managers and directors
Software vendors, hosting providers
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