Webinars >>FDA Guidance Documents
How to Use FDA’s Guidance Documents To Your Advantage

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:
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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
Date: April 25, 2019
​Duration: 90 Minutes
​Time: 12 PM EST

Speaker: Mukesh Kumar
​PhD, RAC | Brij Strategic Consultations,  USA
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    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com