Overview

This Solution Provider Webinar is brought to you by DIA in cooperation with
Sciformix Corporation

Warning letters are issued by the US FDA when, based on available evidence, it has found that an organization has violated a specific rule in a regulated activity. While they are characteristically informal and advisory, their ultimate aim is to establish voluntary compliance with the law. Receiving a warning letter is a cause for real concern to companies regardless of size. However, when the FDA issues warning letters to Pharmaceutical companies for pharmacovigilance (PV) issues, it has been found that most are due to weak PV fundamentals which lead to noncompliance with the 15 day adverse event (AE) rules, PADER submissions and adherence to SOPs to name a few. This webinar will evaluate warning letters from the perspective of small and large pharmaceutical companies. The expert PV panel will present best practices and recommendations that can be employed to improve a PV organization’s structure, develop appropriate SOPs and processes, track important PV functions, and ensure inspection readiness.

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Featured topics

What are USFDA ‘Warning Letters’?
Why should you be concerned about warning letters?
Evaluation of FDA warning letters from the perspective of small and large pharmaceutical companies
Best practices to ensure compliance in PV

Who should attend?

Professionals who work in the area of:

PV and Risk Management, including safety/pharmacovigilance operations
Regulatory Affairs
Quality Assurance
Audit

Learning objectives

At the conclusion of this webinar, participants should be able to:

Explain why warning letters are issued and the possible implications
Analyze warning letters and reasons cited for noncompliance
Recognize the importance of PV operations in the context of warning letters, from the perspective of small and large pharmaceutical companies
Employ best practices to avoid compliance issues

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Complimentary - What to Learn from US FDA Warning Letters and Their Impact on Pharmacovigilance Operations

Overview

Featured topics

Who should attend?

Learning objectives

Be informed and stay engaged.