Computer System Validation


OVERVIEW
According to the FDA requirements all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than validation of device software (embedded software). Computersystem validation is more than testing. It is testing plus design control and configuration management.
How to plan and conduct a risk based validation will be explained. Overall risk for computer system is a combination of software complexity and product risk as determined by probability, severity and detectability rankings. Also involved in the risk evaluation is the requirement for purchased software supplier qualification. In this computer system validation training you’ll learn how to integrate risk based supplier evaluation into the computer system validation process.
Validation Master plan and System Validation Plans will be explained.
Testing, based on risk, includes requirements validation and IQ, OQ and PQ. A procedure for each level of complexity and risk will be described.
WHY SHOULD YOU ATTEND
Validation of computer system software is completely different than validation of device software (embedded software). Attempting to conduct a CSV following device software validation concepts could result in a 483 or rejection of a product approval submission.
AREAS COVERED
  • Computer system validation strategy
  • Requirements documentation
  • Complexity and risk analysis
  • Creating a detailed test plan based on risk
  • Supplier qualification
  • IQ, OQ and PQ
LEARNING OBJECTIVES                                      
  • Computer system validation life cycle models and Validation Plan contents
  • How to determine the complexity category of your system based on GAMP 5 principles
  • Guidelines on how to evaluate risk level using GAMP 5 modifications to the ISO 14971 procedure
  • What level of testing is necessary based on software complexity and risk
  • Integrating software supplier evaluation into the computer system validation in pharmaceutical industry
  • What requirements documentation is necessary
  • How to plan and conduct IQ, OQ and PQ
WHO WILL BENEFIT
  • IT Staff
  • Computer System Users
  • Quality Assurance
  • Regulatory
  • System Vendors

For more detail please click on this below link:
https://bit.ly/2Pl2Ei9


Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882







Comments

Post a Comment

Popular posts from this blog

BCBS 239 – Principles of Effective Risk Data Aggregation and Risk Reporting

Image
OVERVIEW Understanding the process required to ensure compliance withBCBS 239 as well as tips on ensuring that the right data is utilized. Finally, a detailed step by step analysis of COSO requirements and what a business can do to meet expectations. COSO continues to provide guidance and establish standards for performance in risk related processes.  BCBS 239 is the latest in a series of instructions which focuses on risk data aggregation. This webinar will include discussions on the risk data aggregation capabilities and internal risk-reporting practices (the Principles) that enhance risk management and decision making processes at financial institutions. BCBS 239 Compliance WHY SHOULD YOU ATTEND Early in 2015, the Basel Committee published the second progress report on bank’s adoption of BCBS 239. Several banks, at that time, stated that they would not be able to comply with the new standards by the 2016 deadline date.  However, regulators are now looking a...
Read more

Effectively Handle Toxic People for Better Productivity and Less Drama in 2020

Image
We all have people who push our buttons and if that relationship is with our boss, colleagues or clients, it can drain our energy, take us off track and infect the other areas of our life. Our upcoming webinar discusses successful strategies and tips for building a positive, productive relationship by knowing how to effectively respond to, cope, and manage the impact of their negative and toxic behavior in the workplace. The webinar covers the following key areas: ·          Identify and control the impact of difficult people so that you can keep the situation from escalating further ·          Differentiate the 4 types of attitudes and understand how they develop in order to keep your cool in a variety of situations ·          Utilize various verbal and non-verbal communication techniques and situational strategies that you can use to de-escalate and effe...
Read more

Handling a Chaotic Work Environment: How to Prioritize Work and Make Good Decisions Under Pressure

Image
OVERVIEW This highly interactive webinar offers you and your team an array of practical tools to help you get things done in today's chaotic and constantly changing work environment. You’ll learn practical tips on how to make good decisions under pressure to earn buy-in from bosses, coworkers and customers. In a workshop environment, you will participate in valuable exercises utilizing real-world case studies.  You'll emerge with an action plan you can use right away for managing through chaos and to master expanding workloads and complex decisions. WHY SHOULD YOU ATTEND • Are you feeling overtasked, over-worried and overdone? • Could you use a ‘managing multiple priorities effectively refresher”, to help you get a better handle on things? • Would you like to brush up on your management and delegation skills? If you answered  “yes”  to any of these questions, then come laugh, listen and learn as Chris DeVany leads us all through those important topics, ke...
Read more