Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
Short course
Online
*Indicative price
Original amount in USD:
$ 150
Description
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Type
Short course
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Level
Advanced
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Methodology
Online
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Class hours
2h
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Duration
1 Day
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Start date
October
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Virtual classes
Yes
It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.
Facilities
Location
Start date
Start date
Reviews
Subjects
- Compliance
- Compliance Trainings
- Healthcare
- Medical courses
- Online Trainings
- Compliance education
- Industrial courses
- Technical courses
- Fda inspections
- Knowledge
Teachers and trainers (1)
Adam Fleming
Event Manager
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements.
Course programme
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.
Areas Covered in 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
Who Will Benefit:
- GMP, GCP, GLP, Regulatory Professionals
- QA/QC
- IT
- Auditors
- Managers and Directors
- Software Vendors, Hosting Providers
Additional information
Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
*Indicative price
Original amount in USD:
$ 150