Akorn v. Fresenius Merger Litigation: A Deep Dive into FDA Data Integrity

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Introductions & Call Background

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Background: Jackgarvey, Founder & CEO

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What Is Data Integrity?

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FDA Enforcement & Current Climate

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Data Integrity and Akorn

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Akorn v. Fresenius Merger Litigation: A Deep Dive into FDA Data Integrity

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Akorn v. Fresenius Merger Litigation: A Deep Dive into FDA Data Integrity

Introductions & Call Background

Explore FDA data integrity with Jack Garvey, CEO of Compliance Architects, in a confidential Q&A session with an investment advisory firm.

Background: Jackgarvey, Founder & CEO

Jack Garvey, a chemical engineer and attorney with 30+ years' experience, discusses FDA-regulated manufacturing and data integrity remediation.

What Is Data Integrity?

Data integrity ensures reliability, credibility, and validity of information. Jack Garvey explains FDA's ALCOA criteria.

FDA Enforcement & Current Climate

Garvey highlights increased scrutiny on data integrity in the FDA's enforcement approach despite a more industry-friendly environment.

Data Integrity and Akorn

Explore Akorn's data integrity issues, including 483s in Switzerland and Decatur. Garvey suggests potential cultural deficiencies and emphasizes the significance of investing.

Akorn v. Fresenius Merger Litigation: A Deep Dive into FDA Data Integrity