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Press Release

Compliance4All to host 3-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11 on July 12

Netzealous LLC DBA - Compliance4All
Posted on: 21 Jun 18
Compliance4All to host 3-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11 on July 12

Fremont, CA: Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, has announced that it is hosting a 3-hour virtual seminar on FDA's new enforcement of 21 CFR Part 11. Ludwig Huber, Director and Editor of Labcompliance, the global online resource for validation and compliance, will be the expert at this webinar. Please visit to enroll for this session.


Part 11 continues to be an area of concern to companies in many FDA-regulated industries. From the time the FDA's new enforcement of 21 CFR Part 11 came into effect, no fewer than 30 Warning Letters have gone out, purely on the subject of Part 11-related observations. The most common reasons for which these citations have got issued are inadequate integrity, security and availability of electronic records, including data manipulation.

Although Part 11 and GMPs set forth minimum requirements to assure that drugs meet the FDA’s standards relating to the safety, identity, strength, quality, and purity of a medical product; there is the element of subjectivity at the FDA’s inspections. Since regulations are subject to the inspector's interpretations; inspectors can frequently ask more, making the inspections unpredictable at times. The axiom that Part 11 regulation is spelled out very clearly and is well understood by regulated companies, but FDA inspections are not, summarizes the whole situation best.

Understanding what the FDA inspectors are looking for

So, this calls for a serious look into what the FDA inspectors are looking for, how they arrive at their findings, and what the FDA expects in relation to follow-ups. The aim of this 180-minute webinar is to provide answers to these and related questions. The expert at this webinar, Dr. Huber, who has authored the books, Validation and Qualification in Analytical Laboratories and Validation of Computerized Analytical and Networked Systems, and has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world; will show participants how to avoid 483 inspectional observations and Warning Letters. He will use industry-proven case studies that will help the participants learn how to prepare their organization for trouble-free Part 11 related inspections.

This learning is critical because FDA enforcement results in many negative consequences for organizations, which include:

  • A severely negative impact on the company's reputation
  • Stopped shipments, which lead to loss of revenues and profit
  • Product recalls
  • Import alerts
  • Consent decrees.

Learning on how to avoid the FDA’s penal actions

When the FDA takes actions such as these; the company would have to undertake extensive corrective and preventive actions, for which they may have to even hire the services of third party specialists and consultants.

The most important takeaway of this webinar is that participants will learn recommendations on how to avoid observations based on the over 20 practical, real life inspectional observations that Dr. Huber will present from his experience. The participants will be able to interact with the expert on how this can be accomplished, and will have the opportunity to hear from the Part 11 and Data Integrity expert.

Editor's Details

Event Manager
Netzealous LLC DBA - Compliance4All

Last updated on: 21/06/2018

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