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.
Catalog: 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.Training Program: Validation: Introduction to Software Validation - Part 2
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment. The 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:
Who should take this course
Validation Protocols - DQ/IQ/OQ/PQ
Validation maintenance and project control
Design qualification (DQ)
Installation qualification (IQ)
Software lifecycle management
Supplementing Regulatory Testing
Other test considerations
Ad-hoc or exploratory testing
Test case development considerations
Test protocol layout considerations
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 test failures
Managing the results - The validation package
Maintaining the Validated State
Changes affecting risk of errors
Risk analysis and the trace matrix
Considerations for Commercial and Open-Source Software
Due diligence activities associated with commercial software
Open source systems
Key points moving forward
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.