Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Who Will Benefit

  • GMP, GCP, GLP, regulatory professionals
  • QA/QC
  • IT
  • Auditors
  • Managers and directors
  • Software vendors, hosting providers

Webinar Takeaways

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

Agenda

1. What 21 CFR Part 11 means today

• Purpose of Part 11

2. What does Part 11 mean?

• SOPs

• System features

• Infrastructure qualification

• Validation

3. Security standards

• Roles

• Usernames and passwords

• Restrictions and logs

4. Data transfer standards

• Deleting data

• Encryption

5. Audit trail standards

• Types of data

• High risk systems

6. Electronic approval standards

• Electronic signatures

• Single sign-on

• Replacing paper with electronic forms

7. Infrastructure qualification

• How to efficiently document qualifications

8. Validation

• Software validation for vendors

• Computer system validation for users

• Fill-in-the-blank templates

• Change control re-validation

9. SaaS/Cloud hosting

• Responsibilities for software vendor and hosting provider

• Evaluation criteria

• Hosting requirements

10. SOPs

• IT, QA, validation

• Software development

11. Annex 11

• Comparison with Part 11

Overview

 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.

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Faculty David Nettleton Owner, Computer System Validation and FDA Compliance consultant David Nettleton

Faculty 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. He 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. His most 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. 

Choose a Purchase Options

$199

Live Webinar - Single Participant 60-mins

You get one log-in for the live 60-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email


$399

Group Up to 5 Participants ( MP3 Download Free )

You get 5 log-in for the live 60-minute webinar for all the participant, presentation materials , MP3 Download and the opportunity to ask questions by phone and email

$299

Recorded Access Corporate Group

You'll have access to group log-in for an archived recording of the entire 60-minute webinar, including the Q&A period, for 1 location. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the sessionx

$389

MP3 Download - Training DVD

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.

$289

Live + Recorded Access - Single Participant

You get one log-in for the live & recorded 60-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email