The European Parliament and the European Council have developed the General Data Protection Regulation (GDPR), a legislation aimed at protecting and securing data rights for the citizens of the European Union (EU). The GDPR applies to companies that carry out business transactions with European Union citizens. The companies’ mobile phones, their desktop applications, and websites are among the prime objects that are governed by this regulation.
The GDPR was completely reenacted, replacing the earlier law on data protection, the Data Protection Directive, on May 25, 2018. The new data protection law, the GDPR, is the extant law on this subject, replacing the Directive that was in force for about two decades.
It is mandatory for companies that collect or process data of EU citizens, to inform them how these personal data is collected, used, shared, secured and processed. This is the soul of the new regulation. Any company that deals with information pertaining to what is described as personal data by the EU has to show compliance with this regulation. The cost of non-compliance is exorbitant: it can attract fines of up to €20 million, or up to one-twenty fifths of the company’s total annual revenues, depending on which of the two is higher.
It is to help companies understand the core aspects of data privacy relating to 21 CFR Part 11 and SaaS-Cloud, that Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar. The aim of this 90-minute learning session, which will be organized on April 11, is to help participants understand how to write a Data Privacy Statement for compliance with the GDPR regulation. The Data Privacy Statement is a crucial document that sets out how businesses use the private data of EU citizens.
To gain knowledge of how to craft this extremely vital document, the appropriateness or lack of which can be the difference between compliance and penalties, please log on to https://t2m.io/S6yAtmuE to register.
The expert at this webinar is David Nettleton, an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. David will describe just what companies need to do to be compliant with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. He will show the proper ways of writing a Data Privacy Statement that meets the compliance requirements set out by the GDPR.
He will explain this through an explanation of all the four primary compliance areas that this law applies to:
- Software features
- Infrastructure qualification, and
The aim of this learning is to show to participants the right manner of using electronic records and signatures. Doing it in the right manner goes a long way in helping to increase productivity and in ensuring compliance.
These are the core objectives that the learning from this webinar will impart:
- 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.
This webinar on simple tips to know about SaaS-Cloud: Data Integrity Compliance with 21 CFR Part 11, SaaS-Cloud, and EU GDPR is suited for GMP, GCP, GLP, Regulatory Professionals, QA/QC, IT, Auditors, Managers and Directors, Software Vendors and Hosting Providers.
About the speaker: David Nettleton specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.
His latest book, “Risk Based Software Validation – Ten easy Steps”, relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications.