Course Title:

Computer System Validation (CSV) Training Course

Course Description & Objective: 

This is an Online training course designed to provide a thorough understanding of Computer System Validation, why it is needed, different types of validation, applicable regulations/guidance/standards. In addition, you will also learn how to bring a computer system into a validated state, how to performing GXP/part 11/risk assessment, validation deliverable and steps to maintain a system in validated state.

In addition, this course will help participants understand the relationship of CSV and SDLC and Change Management. 

This course will also focus on resume building and interview preparation. 

Who Can Attend?

Anyone who have attended Software Quality Assurance and Testing course or have a minimum of 2 years of experience working in the field of Software QA & Testing. 

We will provide you with course materials, and walk you through scenarios from the real time business applications.

Course Content:

• • Session 1: Brief History on Regulations 

  •  Session 2: Drug Development Life Cycle 

  • Session 3: Understanding Validation 

  • Session 4: CSV – Regulations/Guidelines 

  • Session 5: GxP and Part 11 Assessment (Exercise) 

  • Session 6: Risk Based Validation  

  • Session 7: CSV and SDLC  

  • Session 8: Requirement Elicitation (Exercise) 

  • Session 9: Validation Plan 

  • Session 10: Qualification Phase 

  • Session 11: Validation Summary Report & Trace Matrix 

  • Session 12: Maintaining Validated State 

  • Session 13: Project Assignment 

  • Session 14: Project Review 

  • Session 15: Resume Building & Interview Prep 

  • Session 16: Final Q&A 

Format:

This is an online instructor based course. 

Duration: 

Total approximate duration of this course is 40 hours.  This course is offered in Fifteen 2.5 hour virtual sessions.

Material:

An electronic copy of the learning material are included in the course and  will be provided in a separate email.

Following are the minimum system requirement to participate in this online instructor based course.

Registration Email:

After registration, you will receive a confirmation email

If you do not, please check your email junk, or spam folder.  Please contact us, in case if you dint get the email.  

For joining online class, you will receive a separate email 24 hours prior to the training schedule with access instructions.

Technical Requirements:

• Computer PC/Laptop
• High speed internet connection
• Windows: IE/Chrome (Latest Version)
• MAC: Safari/Chrome (Latest Version)
• Phone/Headphone with Mike

Additional Requirements:

Deactivate any pop-up blocker and company firewall in case online meeting client is prevented to start.

AnumTech Systems reserves the right to re-schedule courses and to change instructors. Please be advice that in the event of a course cancellation, AnumTech Systems is not responsible for any expenses you may incur to attend the course.

If you need to cancel, we will refund your paid registration fee as noted below :

• Request for cancellation/transfer received at least 5 business days before the start of the course receive a full refund/transfer.
• Request received within 5 business days of the course starting incur a $100 processing fees.
• After the course starts, there will be no refund or transfer.
• Registrants who fail to attend without advance notice are liable for the entire course fee, there will be no refund issued.

Mr. Azam
CSQE, CQA, PMP, Certified Tester, MCSD