21 CFR Part 11 Data Integrity: How to Validate Software for SaaS/Cloud, EU, GDPR

  • Speaker:David Nettleton
  • Date: 13th September 2018 10:00 AM PST | 01:00 PM EST
  • Duration:70Min
  • Product Code:GRC-90336

$169

26

DAYS
Left to Register

Live Session - How it works

  • Username and Password will be sent to you within 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
  • Login to the session by clicking on “Join the Meeting” in the login instructions and then dial the number to connect to the meeting audio or use your Computer to connect to audio. Please use the name and the email address you used at the time of registration to join the meeting.
  • Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information about our products contact +1- 248-233-2049)

Contact support for any questions. To pay by Check or Wire email us at support@grcts.com to prepare an invoice. 

Description:

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.

Learning Objectives/Areas Covered: 

  • 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, and 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/Target Audience: 

  • Computer system users
  • IT
  • QA
  • QC
  • Laboratory staff
  • Managers
  • GMP, GCP, GLP Regulatory Professionals
  • Auditors
  • Software vendors, Hosting Providers

Industries:

  • Pharmaceutical
  • Medical device
  • Biologics
  • Food
  • Cosmetics
  • FDA Regulated Companies
  • Software Vendors
  • SaaS providers
  • Data centers

Upcoming Webinar by David: 

August, 22, 2018 - Excel Spreadsheet Validation-Step by step guide to compliance

Instructor Profile:

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, 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 270 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

Available Options

Live Meeting Access Single: Attend the meeting Live via Webex Meeting

$169

2 Single Live Access: 2 people can attend the meeting Live from any location

$279

3 Single Live Access: 3 people can attend the meeting Live from any location

$349

5 Member Group: 5 can Attend Live Meeting Online from any location globally

$539

10 Member group: 10 can Attend Live Meeting Online from any location globally

$839

Related Products

Validation and Control of Excel Spreadsheets in Regulated Environments

Validation and Control of Excel Spreadsheets in Regulated Environments

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Description:Excel Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 1..

$269

Validation and Use of Cloud Computing in FDA Regulated Environments

Validation and Use of Cloud Computing in FDA Regulated Environments

Description:Cloud computing can significantly reduce investment and operating costs for IT operations. However when used in FDA and other regulated environments they need to be validated to ensure consistent on-going performance and security and integrity of stored and managed data. While there are guidelines available on how to deal with standard networks this is not the case for virtual networks and cloud computing, This seminar will give a good understanding of FDA requirements of cloud compu..

$269