Description
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features, and validation (10-step risk-based approach).
Areas Covered in the Webinar:-
- 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
Agenda:-
- What 21 CFR Part 11 means today
- What does Part 11 mean?
- SOPs
- System features
- Infrastructure qualification
- Validation
- Security standards
- Roles
- Usernames and passwords
- Restrictions and logs
- Data transfer standards
- Audit trail standards
- Types of data
- High-risk systems
- Electronic approval standards
- Electronic signatures
- Single sign-on
- Replacing paper with electronic forms
- Infrastructure qualification
- How to efficiently document qualifications
- Validation
- Software validation for vendors
- Computer System Validation for Users
- Fill-in-the-blank templates
- Change control re-validation
- SaaS/Cloud hosting
- Responsibilities for the software vendor and hosting provider
- Evaluation criteria
- Hosting Requirements
- SOPs
- IT, QA, validation
- Software development
- Annex 11
- EU GDPR
Frequently Asked Questions:-
- How do you suggest communicating to the vendor the importance of all versions (even minor) being validated prior to implementation?
- All log-ins and log-outs must be visible in the audit log. even log outs due to inactivity?
- Does Single Sign On (SSO) capability go against the "passwords are not remembered" rule?
- For the new Data Privacy role will that be a QA or IT position?
- What exactly is the validation that needs to occur each time my vendor deploys a minor or major release?
- How can we get access to infrastructure qualification templates?
- You talked about data retention, so is the data supposed to be deleted or archived from a compliance perspective?
- Do you have any advice for validating software systems that were in place for many years prior to being required to have validation reports?
Why Should You Attend:-
This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with the EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.
Who Will Benefit:-
- GMP, GCP, GLP, regulatory professionals
- QA/QC
- IT
- Auditors
- Managers and directors
- Software vendors, hosting providers
Tokyo
Tokyo is the capital of Japan.