Quality Assurance of Computerized Systems- A Comprehensive Perception

Early Registration Discount
Early registration until January 26, 2020
3,330 NIS + VAT
Registration from January 27, 2020
3,700 NIS + VAT

Date: 5, 6 February 2020
Location: Kfar Maccabiah, Ramat Gan
General Information
Duration: 2 Meetings
Hours: 09:00 – 17:00
Price: 3,700 NIS + VAT
Credit Points: 2
SKU: 20173
Course Language: Hebrew
About the Course
Today, computerized systems used in production and business processes of an organization constitute an integral component of all biopharmaceutical industries and laboratories - including R&D and production of pharmaceuticals, medical devices, biotech, clinical trials and other industries that serve these fields. The healthcare authorities which inspect the biopharmaceutical products require the manufacturers to demonstrate a quality system that defines a comprehensive and homogenous perception for the computerized systems' which will ensure their consistency, traceability, defined validation processes and full compliance with the regulatory requirements.
Quality Assurance of computerized systems in a regulated environment includes a definition of policy and work procedures, implementation of processes based on software development life-cycle, change control and a constructed validation process which are a direct result of a risk assessment procedure.
Who should attend
QA personnel, QA managers, IT project managers for development and implementation of computerized systems, IT personnel, software developers, software testers, instructors and implementers of computerized systems
Quality Assurance of Computerized Systems- A Comprehensive Perception
Benefits to the Participants

  • Learn the standards and guidelines related to QA of computerized systems
  • Learn the characteristics and functionality of computerized systems in the production and business processes
  • Acquire the ability to construct the required set of Standard Operating Procedures (SOPs) for computerized systems according to the nature and activity of the company
  • Learn to construct the validation process based on software development life-cycle and gain the ability to implement it in the organization
  • Acquire the skills to handle regulatory inspections
  • Gain the ability to perform internal audits for computerized systems
  • Learn how to perform vendor assessment and supplier audits for computerized systems
  • Understand the FDA requirements in "21 CFR part 11" rule, gap analysis and guidelines for implementation in different types of computerized systems
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Issues to be covered
  • The working environment of computerized systems
  • Policies and SOPs  for QA of computerized systems
  • Characterization and specifications of computerized systems
  • Validation and life cycle of computerized systems
  • Change Control in computerized systems
  • Management of Validation: from early development to final completion
  • Iplementation of "part 11" requirements in computerized systems
  • Regulatory requirements for computerized systems and compliance
  • Preparations for audits according to authorities observations and warning letters
* The seminar includes examples and workshops that enable personal experiencing and profundity in the learned subjects.
About The Lecturer

Ms. Daphna Spector-Grossbard

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