How to Use FDA's Guidance Documents To Your Advantage

How to Use FDA’s Guidance Documents To Your Advantage

Date: June 2, 2025
Duration: 60 Minutes
Time: 12 PM EST

Companies frequently struggle with interpreting the advice provided in FDA’s Guidance Documents. A favorable but incorrect interpretation could cause delays, disruptions and disrepute with the FDA reviewers while a more conservative reading could leads to overkill and waste of resources. FDA has released more than 4000 Guidance Documents on practically all areas of compliance and plans to release about 100 new such documents every year in the near future. As the number of these advisory documents increase, the uncertainty about how best to use them in a given situation also increases. Although the guidance document hold a prominent disclaimer that the information contained is not binding on either the FDA or the companies, these documents are practically the law. They describe the current thinking of the Agency and no discussion with the FDA is complete without referring to one or more guidance docs. Most guidance documents try to cover broad perspectives regarding all possible scenarios regarding a given issue. FDA expects that the affected companies will review, interpret, analyze and customize the provided information to their specific situation. Easier said than done.

Why should you attend:
This webinar, presented by a leading regulatory affairs expert, discusses best practices for using a given Guidance Document to your advantage using techniques to establish the perfect balance of positive and cautionary interpretation. The presenter will discuss how to find information not available in the published Guidance Documents but was critical in the development of given one. The webinar will discuss when and how Guidance Documents should be used, strategies to interpret and best practices to get additional advice from FDA. The session will highlight key regulatory requirements, dos and don’ts, common areas of concern, and trouble-shooting Guidance Documents using case studies and examples from the presenter’s vast experience helping companies big and small in complying with FDA requirements. This one of a kind seminar will clarify several practices that could make following an FDA Guidance Document a breeze. The training is designed to provide a well-rounded training to all stakeholders in all aspects of the FDA Guidance Documents.

Areas Covered in the Session:

How does FDA create Guidance Documents
How to find the most relevant and current Guidance Documents
What to do if there is no relevant Guidance Document
How does FDA read its own Guidance Documents
Legal and practical interpretation of information contained in Guidance Documents
Best practices for applying a given Guidance Doc to your situation
Permitted and not-permitted deviations from Guidance Docs
Best practices for discussing Guidance Documents with the FDA
Common errors and potential solutions

Who will benefit:

Regulatory affairs personnel
Quality assurance personnel
Regulatory intelligence personnel
Senior managers, VPs, CEOs and senior management
Project managers
People interested in investing in the FDA-regulated industry

Speaker: Mukesh Kumar

PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Single Registration

$199

Group Registration (5 Persons)

$699

Group Registration (10 Persons)

$1199

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

We accept credit card, debit card, and PayPal.

Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.

In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.