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FDAnews annuncia: il database del modulo 483: la risorsa dell'insider su...

Data:

Notizie dalla FDA del WCG

Notizie dalla FDA del WCG

Is one prepared enough for when an FDA investigator shows up at the door for an inspection? Is one worried about 483s and passing the FDA good manufacturing practices, good clinical practices or preapproval inspections? Does one want to know what the investigator is looking for?

Subscribe to Form 483s Database. This database enables subscribers to learn from others’ inspections mistakes, gives subscribers a step up and helps subsribers avoid low-quality suppliers.

This comprehensive resource takes the mystery out of 483s, providing thousands of 483s examples received by companies, labs, trial sites and investigators over the past decade.

With unlimited access subscribers can:

  • Learn in advance about the people who conduct FDA inspections: Does an investigator take a special interest in one area or another?
  • Discover how many companies in a region or area of business have turned in less-than-stellar inspection performances recently: Is there a trend that can help one be proactive in fixing the company’s problems?
  • Understand how the FDA describes violations and noncompliance issues: What does the agency mean by terms such as failure to follow written procedures, lack of complaint investigation and corrective and preventive action?

The Form 483s Database is an essential tool to prepare for the next inspection. It’s robust with thousands of downloadable 483s; fully searchable by date, category, company name, investigator name, region and key words; and up-to-date with new documents added each week.

Start a one-year subscription to Form 483s Database for only $997. Be prepared to ace the next inspection and stay in compliance!

Dettagli banca dati:

Form 483s Database

https://www.fdanews.com/483offer

Banca dati:
$997

Modi facili per registrarsi:

In linea: https://www.fdanews.com/483offer

Per telefono: 888.838.5578 o 703.538.7600

Informazioni su FDAnews:

FDAnews è il principale fornitore di notizie e informazioni commerciali, legislative e normative nazionali e internazionali per i dirigenti dei settori regolamentati dalla FDA statunitense e dall'Agenzia europea per i medicinali. I professionisti dei dispositivi medici e farmaceutici si affidano alle newsletter, ai libri e alle conferenze cartacee ed elettroniche di FDAnews per rimanere in conformità con gli standard internazionali e le normative complesse e in continua evoluzione della FDA

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Source: https://www.prweb.com/releases/fdanews_announces_the_form_483s_database_the_insiders_resource_on_inspection_trends_and_developments/prweb18157980.htm

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