Why and How Do We Fail an FDA Inspection?

[Joseph Wilcox]

Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, is organizing a 60-minute webinar on the topic, “Why & How do we Fail an FDA Inspection”. Vikram Kulshreshta, a Senior Management Professional with a strong experience in Quality Assurance & Regulatory Affairs, will be the speaker at this session. Please visit https://www.traininng.com/webinar/why-&-how-do-we-fail-an-fda-i... to enroll for this webinar and gain clarity on how to face an FDA inspection successfully.

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An FDA inspection, as is well known among organizations in the industries in which it is carried out, can be quite a task for those who face it. There are procedures and methods, which, when followed, make an FDA inspection a lot easier. Yet, it is one of the most dreaded activities for an FDA-regulated industry. While this has been a fact of FDA inspections, a few procedural and technological changes have been taking place, complicating the matter further.

For instance, the organization is moving more towards making their filing and other operations paperless. This is being done with the aid of specific software applications. This has brought about a change in the mindset of the FDA inspectors, who are now becoming more investigative and less consultative in their approach.

In situations like this, the emphasis gets shifted to the person who is performing the FDA-related activity in any organization. Although methods and procedures have been prescribed, the person entering these details needs to know these thoroughly. Why is this so? It is because if software or electronic data management could control everything on their own without the need for human intervention, there would be a possibility of a zero-error situation.

This means that the human element is a still a major factor in ensuring FDA compliance. While adherence to standard procedures has seldom been shown to be incorrect; a major part of the FDA observations have been those related to lack of adherence to the established procedures. When the person commits the mistake, either intentionally or otherwise, there is going to be some or another failure or error. Therefore we need to identify the areas, related to human error, which are more prone resulting in the gaps leading to non-compliances.

This webinar will show how to overcome the human error in FDA-related activities and ensure that organizations have what can be called “all time compliance” in the facility. The speaker, Vikram Kulshreshta, will show what the FDA-covered facilities can focus on in order to achieve this objective. In the course of giving a thorough understanding of why and how we fail an FDA inspection, Vikram will help participants with:

• Comprehending the most common areas ignored & its repercussions
• Maximizing the level of compliance by minimizing the human errors.

This session is aimed at those who face FDA inspections directly or indirectly, such as QA, QC, Production, Projects & Engineering, and Maintenance, and will benefit them immensely.

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About the speaker: Vikram Kulshreshta is an expert in designing and implementing the Quality Systems, Qualifications & Validations, troubleshooting and CAPA implementation, and Regulatory Affairs. He has been in the industry for more than 30 years, during the course of which he has gained expertise in international cGMP regulations such as those of the USFDA, MHRA, TGA, ANVISA, MCC, and COFFPRIS Mexico. He has conducted interactive workshops on QMS elements, with real life examples through interactive approaches and case studies. His methods have enhanced learning benchmarks for the participants.