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

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Deadline: May 23, 2019 | Date: May 23, 2019

Venue/Country: Online, U.S.A

Updated: 2019-05-07 14:02:04 (GMT+9)

Call For Papers - CFP

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?industryId=3&webinarid=1385&speakerid=249

Contact Info:

Compliance Key

Email: supportcompliancekey.us

Visit: https://www.compliancekey.us/upcoming-webinar

Phone: +1 717-208-8666