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FDA 21 CFR Part 11 Compliance: Streamline Transition to Electronic Record

26468 E Walker Dr, Aurora, Colorado 80016-6104
26468 E Walker Dr, Aurora, Colorado 80016-6104 Aurora, CO 80016  
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Start:   Tuesday, April 16, 2019  1:00 PM
End:   Tuesday, April 16, 2019  2:00 PM

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Event Features: Business-Related

Neighborhood: Avenue of the Arts


       



http://tinyurl.com/y2b5udg4


OVERVIEW FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient.
FDA has set up regulations that address both data security and patient safety. We will show how FDA 21 CFR Part 11 compliance checklist considers both.
WHY SHOULD YOU ATTEND
Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11.
AREAS COVERED
• Origin of the FDA regulation and changes in interpretation
• Electronic records
• CFR electronic signature
• Data security
• Open, closed and hybrid systems
• Validation methods
• Risk analysis
LEARNING OBJECTIVES
This webinar will explain what FDA 21 CFR Part 11 compliance is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Procedures for controlling electronic signatures and electronic records as described in the FDA regulation will be explained.
WHO WILL BENEFIT
• Engineering personnel
• QA
• IT
• Management
• Compliance Officers

Use Promo Code MKT10N and get flat 10% discount on all purchases
For more detail please click on this below link:
http://tinyurl.com/y2b5udg4
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