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Home » Validation: Implementing Compliant Systems in the Cloud

Validation: Implementing Compliant Systems in the Cloud (ELM-118)

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: Implementing Compliant Systems in the Cloud
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 ReviewsIn this course, you will learn how to implement compliance systems in a cloud environment to meet FDA and European regulatory requirements. We will outline from a technical perspective the cloud and the different service models available. The different deployment models and their considerations for implementation in a GMP environment. The compliance challenges related to security, data integrity, visibility and control and the risk mitigation strategies to reduce or eliminate risk associated to security, data integrity and control.
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: Implementing Compliant Systems in the Cloud 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

Technical Overview of the Cloud
What is the cloud?
Three service models
Four deployment models
Application criticality

Challenges and Risk Factors
Challenges and risk factors associated with cloud systems
Data and security
Trust and reliability
Security risk
Mitigation of risk

Risk Mitigation Strategies for Cloud Based Systems
Risk mitigation
Cloud components
Cloud control
Cloud policies for life science companies
Cloud policies for service providers
Supplier / vendor assessment
Service level agreements
Availability and performance
Change management
Quality of service
Security
Business continuity
Personnel qualification
Testing
Incident reporting & management
Documentation and information ownership
Performance monitoring
Alerts & escalation

Applying a Risk Based Validation Approach for Systems in the Cloud
Risk Based Approach
Avoid Duplication
Supplier Assessment
GxP Impact Assessment
21 CFR Part 11 Assessment
Risk Assessment
Validation Plan
User Requirement Specification
Installation Qualification
Operational Qualification
Performance Qualification
Validation Summary Report
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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