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Quality Assurance of Computerized Systems – A Comprehensive Perception
Today, computerized systems play a crucial role in the production and business processes of organizations across the biopharmaceutical industry. They are an integral part of laboratories, research and development, pharmaceutical and biotech production, medical device manufacturing, clinical trials, and other related fields. Healthcare authorities which inspect the biopharmaceutical products require the manufacturers to demonstrate a quality system that defines a...Continue reading
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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
