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Home » 21 CFR Part 11 - An Introduction

21 CFR Part 11 - An Introduction (ELM-112)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~45 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Electronic Records.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: 21 CFR Part 11 - An Introduction
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsThe main objectives of this course are to give attendees a grounding in the principles of and latest requirements for Electronic Records and Electronic Signatures (ERES). The course 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 computer hardware and software systems used in Manufacturing, QA, Regulatory and the Control of Processes.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


21 CFR Part 11 - An Introduction course is included in the following Professional Certification Programs:



21 CFR Part 11 - Electronic Records & Signitures Professional Certification Program: The Compliance in Electronic Signatures & Records Professional Certification Program covers two areas of training, including and introduction to compliance and compliance with specific respect to regulation 21 ... Learn more

COURSE OUTLINE:


Introduction
Overview
Learning objectives
Who should take this course
Program introduction

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

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

E-Signatures and E-Records Explained
E-Signatures not impacted

Subpart A - General Provisions
Subpart A - General Provisions A-C
Subpart A - General Provisions D-F
Subpart A - General Provisions Conclusion
Subpart A - General Provisions: Sec. 11.2 Implementation
Subpart A - General Provisions: Sec. 11.3 Definitions

Conclusion


Final Exam


Certification

COURSE OBJECTIVES:


Skill Level:
Intermediate

This training program has been developed to train employees with Intermediate Knowledge of 21 CFR Part 11, Compliance with Electronic Records and Signatures.

Online Training: The Benefits of Remote Learning & eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

Contact Us:

For more information on the Biopharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370.

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