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Wednesday, July 26


THE 6 MOST COMMON PROBLEMS IN FDA SOFTWARE VALIDATION AND VERIFICATION

Learn how to avoid the most common problems in Software V&V and practical tips
to ensure successful validation of computerized equipment.

By TheComplyGuide
30 followers
Follow


WHEN AND WHERE


DATE AND TIME

Wednesday, July 26 · 5 - 7pm UTC


LOCATION

Online


REFUND POLICY

Refunds up to 1 day before event


ABOUT THIS EVENT

 * 2 hours
 * Mobile eTicket

Course Description:

This webinar describes the validation planning process with particular emphasis
on avoiding six common pitfalls. Increased use of software from automated
manufacturing and quality systems means increased exposure. Most recalls can be
traced back to computerized equipment, exposing the validation process to
scrutiny. Corporate uncertainty leads to inaction and “wheel spinning.” Many
companies struggle with understanding how to avoid major mistakes when
validating software to FDA standards.

Areas covered:

 * Which data and systems are subject to 21 CFR Part 11 and Annex 11
 * Why compliance makes good business sense
 * Details of FDA regulations/system features as applied to software: security,
   audit trails, electronic signatures
 * Requirements for local, SaaS, and cloud hosting
 * The 6 Most Common Problems in FDA Software Validation & Verification
 * Strategies on how to avoid the most common problems
 * Advice on successful validation project staffing
 * Avoid 483 and Warning Letters

Who Will Benefit:

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

 * System owners - responsible for keeping individual systems in validation
 * Computer system users
 * QA / QC managers, executives, and personnel
 * IT / IS managers and personnel
 * Validation specialists
 * Software quality reviewers
 * Consultants

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.

David 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


TAGS

 * Online Events
 * Things To Do Online
 * Online Classes
 * Online Business Classes
 * #software_validation
 * #fda_csv
 * #fda_validation
 * #fda_verification
 * #software_verification
 * #fda_software_validation


ABOUT THE ORGANIZER

Organized by
TheComplyGuide
30 followers
 * 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
Organizer website
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$245 – $695
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