Introduction

This webinar describes exactly what is required for compliance with 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 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

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

Area 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

Who Will Benefit

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

ENROLLMENT OPTIONS

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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 invo Know More

David Nettleton