Home / Online GXP courses / Regulatory Affairs / Introduction to FDA 21 CFR PART 11 Online Course

Introduction to FDA 21 CFR PART 11 Online Course

 5/5

109

Duration :

1

1 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course :

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

The main goals of this e-learning course are to give learners a grounding in the principles of and latest requirements for Electronic Records regarding FDA 21 CFFR PART 11. The training provides an overview of the FDA requirements with practical examples covering the implementation of those requirements. The course covers the application of these requirements to both hardware and software systems used in Manufacturing, QA, Regulatory, validation and the Control of Processes.

In this course, we provide a synthesis on the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum:

Introduction
Overview
Learning objectives
Who should take this course
Program introduction

Module 1: The Predicate Rules
21 CFR Part 11 explained
Electronic records
What are the predicate rules?
Relationship to the predicate rules
Predicate rules and batch records
Electronic signatures
Handwritten signatures

Module 2: What is Part 11
What is 21 CFR Part 11?
Guideline
Narrow scope and application of Part 11
The benefits

Module 3: E-Signatures and E-Records Explained
E-Signatures not impacted

Conclusion

Final Exam

Certification

Author:

Dr. Patricia Kay

Dr. Patricia Kay is a results focused senior research management professional with over 20 years experience in the life sciences. She has a significant expertise in clinical development, health program management, strategic planning, stakeholder management, business unit operations and personnel management. Dr. Kay has a broad knowledge of cardiovascular disease, immunology, infectious diseases. She takes part in many startups boards.

Reviews:

 5/5

109

An excellent introduction to the FDA 21 CFR PART 11 and all that is associated with it. Really loved the electronic records aspect of the course and the emphasis on why it’s so important from the data gathering side.

$60

Participant(s):

Buy now

Large group ? Request a quote !

This course includes:

One-year access

Updated content every month

Certificate of completion

GxP-Training Benefits

Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
Validated : All our courses are CPD/CEU accredited and we deliver a unique, traceable and authentic certificate to each learner.
Self-paced : access 24/7 to the course during 12 months at your own rhythm.
Smooth Experience : Each course starts with a video and ends with an exam and a valid certificate.
Up-to-date : each course is updated on an annual basis to remain valid along the Regulatory Body recommendations.
Instant Purchase : one click to buy and immediate access. Get certified today.
LinkedIn compatible : get a valid certificate at the end of each training program and publish it on LinkedIn with a Unique and Secure Link to your registered certificate.
HR management : all course programs are available either individually or as a batch to HR managers in order to pilot employees Training, follow their progress and send reminders.
Procurement optimized : instant Purchase Order, Online payment and PDF Invoice.
LMS compliant : each course is a SCORM object that you can distribute through your corporate Learning Management System.