FDAnews Announces — The Form 483s Database. The insider’s resource on inspection trends and developments

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Get the insider’s resource on inspection trends and developments to prepare and avoid 483s, the Form 483s Database.



Form 483s Database
Is one prepared enough for when an FDA investigat or 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 subscribers 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!

Database Details:
Form 483s Database

$997 per site

Easy Ways to Register:
Online: https://www.fdanews.com/483offer
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

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Michelle Butler
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