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David Nettleton
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Data Integrity and Privacy – compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR 2022

Data Integrity and Privacy – compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

Product Id : FDB3450
Category : Clinical & Laboratory, FDA Compliance, Food, Drugs & Biologics, Information Technology, Medical Devices, QualityPresenter : David Nettleton
Scheduled On : April 19 2022 1:00 pm
US/Canada (Eastern Time - ET)
Duration : 75 Minutes

This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with 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.

Learning Objectives:

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

Who Should Attend:

GMP, GCP, GLP, regulatory professionals
QA/QC Departments
IT Departments
Managers and directors
Software vendors, hosting providers

Areas Covered in the Session :

1. What 21 CFR Part 11 means today
Purpose of Part 11
2. What does Part 11 mean?
System features
Infrastructure qualification
3. Security standards

Usernames and passwords
Restrictions and logs
4. Data transfer standards

Deleting data
5. Audit trail standards

Types of data
High risk systems
6. Electronic approval standards

Electronic signatures
Single sign-on
Replacing paper with electronic forms
7. Infrastructure qualification

How to efficiently document qualifications
8. Validation

Software validation for vendors
Computer system validation for users
Fill-in-the-blank templates
Change control re-validation
9. SaaS/Cloud hosting

Responsibilities for software vendor and hosting provider
Evaluation criteria
Hosting requirements
10. SOPs

IT, QA, validation
Software development
11. Annex 11

Comparison with Part 11

Data Privacy Statement

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