US FDA Warning Letters Underline Importance of New Course: “Audit Like the FDA - Effective Internal Audit Program”


Dublin, Oct. 24, 2023 (GLOBE NEWSWIRE) -- In light of the recent warning letters published by the US Food and Drug Administration (FDA) to Gulf States International, Inc. and Zhao Qing Longda Biotechnology Co. Ltd., concerning their lack of response to the FDA’s requests for records, as reported in a recent news article, there has never been a more pressing time to understand and implement an effective internal audit system. Recognising the increasing necessity for stringent audit protocols, the "Audit Like the FDA - Effective Internal Audit Program" 2 day seminar has been added to ResearchAndMarkets.com's offering.

This seminar is more than just a regulatory obligation; it's an invaluable tool for business entrepreneurs and managers. In today's regulatory climate, having a competent audit system isn't just a formality but a crucial component in maintaining and understanding quality compliance.

As highlighted by the FDA’s recent interactions, a large percentage of businesses remain exposed to risks associated with non-compliance. Surveys suggest that up to 75% of companies conduct audits solely because of regulatory mandates, often viewing them as a tick-box exercise rather than as an opportunity for genuine improvement. Yet, it's these very companies that express surprise upon receiving a 483, Warning Letter, or more severe punitive actions. Such repercussions can be mitigated, if not avoided, through a well-planned and implemented audit system.

The “Audit Like the FDA - Effective Internal Audit Program” seminar delves deep into creating and managing an efficient audit program. Rather than seeing audits as bureaucratic hurdles, participants will learn to leverage them to identify non-compliance areas and reduce both compliance and quality risks.

Key Seminar Highlights:

  • Regulatory Expectations: Navigate through the intricate maze of regulatory expectations, ensuring that your business remains one step ahead.
  • Development and Implementation: Understand the intricate details behind creating an audit program that is both efficient and effective.
  • Red Flags and Problem Identification: Learn to spot the tell-tale signs that your current system might not be as effective as you think.
  • Risk Analysis Techniques: Equip yourself with tools to identify, communicate, and manage potential risks.
  • Quality System Linkages: Make sure your audits lead to effective and lasting solutions.
  • Training and Culture: Build an environment that promotes proactive identification, clear communication, and escalation of issues.

In a dynamic landscape where oversight is becoming increasingly stringent, knowledge is power. This seminar promises a blend of lectures, interactive discussions, and practical exercises, ensuring that participants are well-equipped to overhaul or refine their current audit practices. Students will walk away not just with theoretical knowledge but also with the practical skills necessary to implement what they've learned.

For businesses aiming to be on the right side of regulatory bodies, maintaining a robust internal audit system is non-negotiable. In the wake of the FDA's recent warning letters, the message is clear: businesses must prioritize internal audit programs to ensure they are prepared and protected.

The “Audit Like the FDA - Effective Internal Audit Program” seminar is a call to action for business entrepreneurs and managers to empower themselves with the tools and insights to protect and enhance their business's quality and compliance stature.

Ensure your business remains compliant, risk-averse, and ahead of the curve. Join us for this transformative 2-day journey.

For more information about this seminar visit https://www.researchandmarkets.com/r/1l9gwf

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