2019 - Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

Overview
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.
Why should you attend this webinar?
Our Speaker David Nettleton will explain: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
Areas Covered in the Session:
What 21 CFR Part 11 means today
Purpose of Part 11
What does Part 11 mean?
SOPs
System features
Infrastructure qualification
Validation
Security standards
Roles
Usernames and passwords
Restrictions and logs
Data transfer standards
Deleting data
Encryption
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 software vendor and hosting provider
Evaluation criteria
Hosting requirements
SOPs
IT, QA, validation
Software development
Annex 11End
Comparison with Part 11
End
Who can Benefit:
GMP, GCP, GLP, regulatory professionals
QA/QC
IT
Auditors
Managers and directors
Software vendors, hosting providers
Industries:
Pharmaceutical
Medical device
Biologic
Food
Cosmetics
FDA Regulated Companies
Software Vendors
SaaS providers
Data centers
Industries:
Pharmaceutical
Medical device
Biologic
Food
Cosmetics
FDA Regulated Companies
Software Vendors
SaaS providers
Data centers
Speaker Profile:
David Nettleton is a keynote speaker of ComplianceKey. Computer System Validation's principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Data Protection Regulation (GDPR), 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 280 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten Easy Steps, which provides fill-n-the-blank templates for completing a COTS software validation project.
Register: https://www.compliancekey.us/webinarDetails?indust...
Contact Info:
Compliance Key
Email: support-AT-compliancekey.us
Visit: https://www.compliancekey.us/upcoming-webinar
Phone: +1 717-208-8666