Learnings from the 2018 Warning Letters Issued in Pharma Industry

Event Information
Product Format
Live Webinar
Conference Date
Add to my calendar   Tue, Jan 15, 2019
Aired Time
1 pm ET | 12 pm CT | 11 am MT | 10 am PT
90 minutes
Product Description

Avoid Warning Letters in 2019 by Learning From 2018

Learning from others' mistakes is a great approach to adopt when it comes to warning letters, which are among the most undesirable and unwelcome documents in the pharma industry. A warning letter is one of the agency's principal means of achieving prompt voluntary compliance with the Food, Drug, and Cosmetic Act. While the FDA generally determines violations through its own inspections, it can also issue a warning letter based on evidence from state personnel. But despite its disconsolate nature, a warning letter is a great source of information; trends of quality issues, and typical pitfalls your organisation can have on the road to compliance.

Dig into all that valuable information in this insightful webinar by industry expert Milind Nadgouda. Nadgouda will share how the information and trends that can be seen in the warning letters issued across different types of organizations give an insight into gaps within quality management systems, processes, and establishments.

After attending this webinar, you will benefit from a summarized data overview; trends, and an expert view point on what can be learnt from these; what to watch out for whilst preparing towards regulatory compliance and ensuring continuous quality.

Session Highlights:

This webinar will walk you through the following areas:

  • Warning letters: what are they after all?
  • Issuing authorities and what do they warn?
  • Metrics for warning letters
  • Trends in the issues highlighted in warning letters
  • Top trump items that make the warning letters
  • Issues in the loop—how do issues appear and reappear?
  • Lesser known trends
  • Is human error an issue that is reported in warning letters?

Who Should Attend

  • CEOs
  • Regulatory VPs
  • Quality VPs
  • IT VPs
  • Regulatory affairs professionals
  • Quality managers
  • Quality engineers
  • Small business owners
  • GxP consultants

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Milind Nadgouda

Milind Nadgouda is a seasoned quality and regulatory professional with 19 years of industry experience. He is the co-founder and director at RiverArk Limited, a quality consultancy providing services in the GxP space. His core areas of specialisation are risk strategy (identification, assessment, rating, prevention, and mitigation); regulatory agency inspection readiness, and quality management system GAP analysis.

Nadgouda has worked on different types of quality projects with methodologies such as Six...   More Info
More Events By The Speaker

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