- Speaker : David Nettleton
- Session Code : DNNOV2221
- Date : 22nd November 2021
- Time : This webinar has not been recorded, hence won't be available On-Demand.
- Duration : 90 Mins
Data Integrity and Privacy: 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, 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.
Areas covered during the session:
- 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
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
11
- Comparison
with Part 11
EU GDPR
- Data
Privacy Statement
- end
What industries will benefit from this training:
- Pharmaceutical
- Medical Device
- Biologics
- Food
- Cosmetics
- FDA regulated companies
- Software Vendors
- SaaS providers
- Data Centers.
Who will benefit?
- GMP,
GCP, GLP, regulatory professionals
- QA/QC
- IT
- Auditors
- Managers
and directors
- Software
vendors, hosting providers
David Nettleton 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.
Mr. Nettleton is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 300 mission critical laboratory, clinical, and manufacturing software implementation projects.
Mr. Nettleton recent
book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving
Templates, which provides fill-in-the-blank templates for completing a COTS
software validation project.