Quality Assurance of Computerized Systems – A Comprehensive Perception

Conducted by: גב' Daphna Spector-Grossbard
SKU: 23173
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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...Continue reading

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.

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Dates: 
  • 22/03/2023
  • 27/03/2023
Course location: Bioforum Offices, 3 Golda Meir st., 4th Floor, Weizmann Science Park, Ness Ziona
Duration: 2-Days Course
Hours: 09:00 - 17:00
Credits: 2
Course Language: עברית

Course price: ₪3,700 + VAT
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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.

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

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

About The Lecturer

Daphna Spector-Grossbard
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