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483 Covers a Broad Gradation of Problems

Réf: 25883 Mercredi 25 Octobre 2017 - En ligne

Overview: How you respond to the 483 should provide the foundation for any future communication with the FDA about a particular inspection. Understanding how FDA organizes its evaluation of the 483 can facilitate the FDA’s review in your favor as it is well organized, succinct and provides ...

Formation: Pharmacie, Médecine, Bio-Technologies, Management

NIST Cybersecurity Framework For Computer Systems Validation

Réf: 25884 Mercredi 25 Octobre 2017 - En ligne

Overview:   Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information.  ...

Formation: Pharmacie, Médecine, Bio-Technologies, Management

Guidance on Software and Device Changes and the 510(k)

Réf: 25885 Lundi 30 Octobre 2017 - En ligne

Overview:   The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required.   Why should you Attend: Anyone who is involved in software and device design, ...

Formation: Pharmacie, Médecine, Bio-Technologies, Management

Top 100+ Healthcare webinars You Can Get for $10

Réf: 25836 15/08/2017 -> 31/12/2018 - En ligne

Want to enhance your regulatory compliance career by learning a new course? All that it costs is $10. Yes, GlobalCompliancePanel, a provider of professional trainings, is offering hundreds of high value regulatory compliance courses for a mere $10 each. Regulatory compliance learning, that ...

Formation: Pharmacie, Bio-Technologies, Informatique, Management