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Home » Validation: Managing and Ensuring Data Integrity of E-Records within a Regulated Environment

Validation: Managing and Ensuring Data Integrity of E-Records within a Regulated Environment (ELM-125)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~60 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Validation for BioPharma Companies.
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: Validation: Managing and Ensuring Data Integrity of E-Records within a Regulated Environment
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 ReviewsThis course has been created for anyone who is interested in learning more about managing and ensuring integrity of e-records within a regulated environment. If you would like to expand your knowledge of e-record integrity, but find it difficult to move forward in the process, this course is the perfect starting point. Our course will bring you up to speed with the world of e-record data integrity very quickly, explaining the basics of what is involved. The purpose of this course is to provide an easy launchpad to allow learners to search for more detailed information when it is needed.
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.


Validation: Managing and Ensuring Data Integrity of E-Records within a Regulated Environment course is included in the following Professional Certification Programs:



Computer System Validation for Intermediate Professionals: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more

COURSE OUTLINE:


Introduction
Overview
Learning objectives
Who should take this course?
Course modules

Industry Regulations
The starting point
Definitions
US FDA
Eudralex
More important definitions
Records Vs data
Key points to note

Computer Systems
Key regulations
Risk

Requirements for Computer Systems
The key areas
Security and protection
Accuracy & validity
Audit trails & metadata
Access and presentation
'Open'? Vs 'Closed'? Systems

Deployment
Procedural requirements
SOPs and work instructions
Validation of computer systems

Special Topics
Overview
Archival
Backup file Vs backup copies
Backup copies
Data migration

Conclusion


Final Exam


Certification

COURSE OBJECTIVES:


Skill Level:
Intermediate

This training program has been developed to train employees with Intermediate Knowledge of Computer System Validation.

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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