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Home » Validation: Introduction to Software Validation - Part 2

Validation: Introduction to Software Validation - Part 2 (ELM-119)

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: Introduction to Software Validation - Part 2
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 learners a grounding in the principles of Software Validation, Computer Systems Validation and the documentation associated with a complete Software Validation Lifecycle (SDLC). The course provides an overview of the FDA and European requirements with practical exercises covering the implementation of those requirements. The course covers the application of these requirements to the validation of 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.


Validation: Introduction to Software Validation - Part 2 course is included in the following Professional Certification Programs:



Computer System Validation for Beginning 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
Module overview

Validation Protocols - DQ/IQ/OQ/PQ
Validation maintenance and project control
Validation protocols
Design qualification (DQ)
Installation qualification (IQ)
Physical installation
Software lifecycle management
Personnel
Operational qualification
Performance qualification

Supplementing Regulatory Testing
Other test considerations
Static analysis
Unit-level testing
Dynamic analysis
Ad-hoc or exploratory testing
Test case development considerations
Test protocol layout considerations
Acceptance criteria

Validation Execution and Documentation
Validation execution - Preparing for a test
Executing and recording results
Capturing tester inputs and results
Capturing tester inputs and results - precision
Capturing tester inputs and results - expected results
Attachment page layout
Reporting
Reporting test failures
Managing the results - The validation package

Maintaining the Validated State
Changes affecting risk of errors
Assessing change
Risk analysis and the trace matrix
Indirect changes
General observations
Re-testing
Regression testing
Test invalidation

Considerations for Commercial and Open-Source Software
Commercial software
Due diligence activities associated with commercial software
Open source systems
Excel spreadsheets
Retrospective validation
Key points moving forward
Conclusion

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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