PHARMACEUTICAL COMPUTER VALIDATION

CERTIFICATE TRAINING


Live Session

Certificate Awarded: Computer System Validation (CSV)- Certificate

Time: 9.30 AM – 4.30 PM

Level of Training: Beginners | Intermediate

Mode of Delivery: Live Interactive Instructor-led Webinar

Date: August 21, 2021

Fee: $860

(Contact us for the Recorded webinar)

Webinar Overview

● Computer System Validation is a process used to ensure that computer-based systems will produce information or data that meet a set of pre-defined requirements. If a computer system meets these specific requirements, it can be assumed that it is consistently performing as per your intended purpose.

● This online computer system validation training course focuses on CSV regulatory requirements, CSV Documentation, CSV process, Test cases.

● Anyone who wants to become a Computer Validation Specialist, Front/Backend Development or Enterprise Software, Validation Engineer or Specialist, Control/Instrumentation Engineer, Process Engineer or Project Engineer, Quality Assurance Specialist, Quality Control Specialist, Maintenance Engineer, Automation Engineer, Maintenance Technician, Senior Validation Manager should attend this computer validation training course webinar.

Course Offers

Register for 3 webinars at NACPT and get any available 1-day certificate training for free.

Pharmaceutical Computer Validation

  • Module 1
  • ● Computer System Validation
  • ● Why Do We Need Computer System Validation?
  • ● CSV regulatory requirements
  • ● Computer System Validation Documentation
  • Module 2
  • ● CSV process
  • ● Mapping out a User Requirement
  • ● Writing a Validation Master Plan
  • Module 3
  • ● Test cases – including installation, operational and performance qualification (IQ/OQ/PQ)
  • Module 4
  • ● Validation Protocol
  • ● Validation Report
  • ● Case Study: Protocol Writing
  • After successful completion of this course, students will be :
  • ● Able to understand current computer system validation regulatory requirements
  • ● Benefits of computer system validation
  • ● Develop IOQ, PQ protocols ad per user requirements
  • ● Deploy validation plans and reports
  • ● Able to perform a risk analysis
  • ● Able to perform re-validation
  • ● Validation Assistant
  • ● Validation Specialists
  • ● Coordinators
  • ● Managers
  • Anyone who wants to become the following should attend the webinar on pharmaceutical software validation:
  • ● Computer Validation Specialist
  • ● Front/Backend Development or Enterprise Software.
  • ● Validation Engineer or Specialist
  • ● Control/Instrumentation Engineer
  • ● Process Engineer or Project Engineer
  • ● Quality Assurance Specialist
  • ● Quality Control Specialist
  • ● Maintenance Engineer
  • ● Automation Engineer
  • ● Maintenance Technician
  • ● Senior Validation Manager

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Dean Rathi Param

B.Sc., Post Grad Cert., in Pharma QA QC, (MBA/TECH)

 

She is an innovative and creative leader with more than twelve years of hands-on experience in many scientific industries, complemented with ten years of training/teaching experience.

 

Rathi Param is the president/founder of the North American College of Pharmaceutical Technology (NACPT) and ValidationTech Inc. She is an innovative and creative leader with more than twelve years of hands-on experience in many scientific industries (medical devices, environmental, food, pharmaceutical and biopharmaceutical), complemented with ten years of training/teaching experience. She possesses extensive expertise and knowledge of Quality Control, Quality Assurance, Validation, Technology Transfer, Manufacturing Technology, Process Improvements, Auditing and Inspection.

 

In the past twelve years, Rathi has held strategic management roles in major Canadian name brand/generic pharmaceutical companies. Validation Scientist at Patheon Inc., Validation Services Manager at Sanofi Pasteur Limited, Toronto., Validation Specialist at CibaVision, Toronto., and Validation Quality Engineer (Consultant) at iPOC, Toronto were few to be named.

 

Her interest in helping graduates to commence their careers in the pharmaceutical industry was the motivation to launch NACPT and Validation Tech, to provide hands-on training and create a platform to direct the pathway to successful recruitments by the pharmaceutical companies.

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