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1. Home
2. Courses
3. Data Integrity and Privacy – compliance with 21 CFR Part 11, SaaS/Cloud, EU
GDPR
DATA INTEGRITY AND PRIVACY – COMPLIANCE WITH 21 CFR PART 11, SAAS/CLOUD, EU GDPR
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Sorry, registration has ended.
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Faculty: David Nettleton
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* Date: 10-08-2021 01:00 PM - 10-08-2021 02:15 PM
* Location: Online Event
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DESCRIPTION
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
* Auditors
* 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?
* SOPs
* System features
* Infrastructure qualification
* Validation
3. Security standards
* Roles
* Usernames and passwords
* Restrictions and logs
4. Data transfer standards
* Deleting data
* Encryption
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
12. EU GDPR
* Data Privacy Statement
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* Seminar on FDA Inspection
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