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Wednesday, February 14


WHAT EXACTLY IS REQUIRED FOR 21 CFR PART 11 AND ANNEX 11 COMPLIANCE?





Learn what is required for compliance with Computer Software Assurance guidance,
21 CFR Part 11, and Annex 11 for local, and SaaS.

47 followers

By TheComplyGuide
47 followers
180 events hosted 📈
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DATE AND TIME

Wednesday, February 14 · 7 - 8:30pm CET


LOCATION

Online




REFUND POLICY

Refunds up to 1 day before event



ABOUT THIS EVENT

 * 1 hour 30 minutes
 * Mobile eTicket

Course Description:

This webinar describes exactly what is required for compliance with Computer
Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex
11 for local, and 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:

Upon completion of this session, attendees will learn:

 * 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:

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 the software vendor and hosting provider
 * Evaluation criteria
 * Hosting requirements

10. SOPs

 * IT, QA, validation
 * Software development

11. Annex 11

 * Comparison with Part 11

12. EU GDPR

 * Data Privacy Statement

Who Will Benefit:

This webinar is intended for professionals in the Medical Device, Biotechnology,
and Pharmaceutical Industry. Personnel in the following roles will benefit:

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

About the instructor:

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. 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. He has completed more than 300
mission-critical laboratory, clinical, and manufacturing software implementation
projects. Services are available to guide companies to create and maintain the
systems and procedures required to pass regulatory audits: product features,
vendor audits, software validation, SOPs, training, gap analysis, remediation
plans, and project management.

Refund policy:

Attendees may cancel up to two working days prior to the course start date and
the refund will be processed within two working days.

We will process/provide a refund if the webinar is canceled. Refunds will not be
given to participants who do not show up for the webinar. On-demand Recordings
can be requested in exchange. Webinar may be canceled due to lack of enrolment
or unavoidable factors. Attendees will be notified 24 hours in advance if a
cancellation occurs. Substitutions can happen at any time.

If you have any concerns about the content of the webinar and are not satisfied
please contact us at care@thecomplyguide.com

Read more





TAGS

 * Online Events
 * Things To Do Online
 * Online Classes
 * Online Business Classes
 * #software_assurance
 * #fda_csv
 * #fda_data_integrity
 * #excel_sheet_compliance
 * #fda_excel_compliance
 * #annex_11_compliance
 * #saas_compliance
 * #software_assurance_guide


ORGANIZED BY

TheComplyGuide
47 following this creator
180 events hosted
 * Contact
 * Follow

Comply Guide is a training and content provider in the regulatory compliance
space.

We partner with organizations and individuals to address their unique learning
needs, provide training and coaching to help them gain complete knowledge about
best practices, SOPs, and regulations pertaining to their jobs and/or industry.

View more
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