The Consequences of Non-Compliance in Computer System Validation

An essential piece of the R&D puzzle, computer systems are not only storage places for data in pharmaceutical development, but have become the sites of quality control, automation, and feedback that aids in decision-making throughout the lifecycle of your business.

As computer systems become more sophisticated in the pharmaceutical space, and the capabilities are increased due to artificial intelligence, it has never been more essential for businesses to ensure their computer system validation is rigorous, focused and regularly performed. This process not only impacts the quality of work at the development level, but has far-reaching implications for public health and safety.

In our course Computer System Validation the focus is on strategic action to prevent problems, not just how to find solutions after-the-fact. Participants will also become experts in FDA regulations including 21 CFR part 11. In particular, our instructor has built time into the course to address any questions that participants may have with part 11, and encourages those with current issues to bring their questions to the session, so that everyone may benefit from discussion of real-world problems.

Our knowledgeable instructors are pharmaceutical professionals who have the background to give real, actionable advice to prevent your company from facing FDA audits, warning letters and possible shutdowns due to non-compliance. This Computer System Validation course is designed to ensure compliance with all FDA regulations, and to prepare participants for new developments, such as the transition from GAMP 4 to GAMP 5. The course is designed for professionals in Validation, Quality, IT, and Business and anyone who regularly interacts with and tests computer systems in the pharmaceutical, biotech and medical device industries. While the course is designed for an introductory level, the focus on new developments and regulations makes it suitable for bringing your knowledge base up-to-date with industry trends.

In order to learn more about this course and related courses and programs, please visit our course page or check out the Computer Systems Validation brochure. Early registration guarantees enough space for your team, as well as being eligible for an early bird discount.