Your Ultimate Guide to 21 CFR Part 11 | Electronic Records & Signatures | US FDA GxP Requirements

Описание: Pursue Certification in Clinical Research, CDM & PV using the link below

https://www.udemy.com/course/certific...

In this video we explain in detail the US FDA 21 CFR Part 11 Guideline that is widely used in pharmaceutical, biotechnology, or clinical research fields. This guideline is crucial to maintain the integrity of electronic records and signatures. IN this session we break down 21 CFR Part 11, that sets the standards for electronic records and signatures in regulated industries. which helps in maintaining data integrity and ensuring compliance with regulatory requirements.

#21cfr #usfda #GMPVSCGMP #gmp #CURRENTGOODMANUFACTURINGPRACTICE #GLP #gcp #CGMP #GUIDELINE #SOP #FACILITY #pharmaceuticalanalysis #system #guidelines


Link to most helpful videos:

CRA Interview:    • CRA Interview Questions & Answers: A Compl...  
CRC interview:    • CRC Interview Questions & Answers: A Compl...  
Clinical Research Coordinator:    • Clinical Research Coordinator (CRC) - Inte...  
Clinical Research explained under 5 mins:    • 5 minute Crash Course in Clinical Research...  
13 Principle of ICH-GCP:    • 13 principles of ICH GCP - Good Clinical P...  
CRC or CRA:    • Starting Clinical Research career as a CRA...  
Phases of Clinical trials:    • What are Phase trials? - Explaining all Ph...  
Good Clinical Practices (ICH-GCP):    • Good Clinical Practices (GCP) and 13 Princ...  
Ethics Committee in Clinical Research:    • Ethics committee in Clinical Research  
NDCT Rules 2019:    • New Drugs and Clinical Trials Rules, 2019 ...  
SAE reporting and SUGAM:    • Serious Adverse events & SAE reporting - W...  
Adverse events (AE) in Clinical Trials:    • Adverse Events & Adverse Drug reactions in...  



For queries about Advanced Certification in Clinical Research, please reach out/contact at below mentioned platforms

Contact: +91 77219 76079 / 83900 88032

To Register, please click on the link below:

https://docs.google.com/forms/d/135mI...

Instagram ID: clinical_aim_research

Gmail: [email protected]

For any queries, kindly comment in the description box below.


In this video, We explain about:

(0:00) Intro
(1:12) What is 21 CFR Part 11?
(2:42) Compliance Requirements
(4:13) 21 CFR system checklist
(7:44) Applications of 21 CFR