This webinar demonstrats the features and requirements of Computer System Validation (CSV) process and why it is important for companies operation in process industry.
Recorded voice over for the presentation entitled FDA Trends: New Validation Strategies at the 2nd International Conference on Continued and On-Going Process Verification, 20th March 2017, Novotel Hamburg, Germany.
If you conduct process validation, you need to ensure that your results are valid. Beyond the regulatory requirements, statistical approaches will help you achieve the desired result - processes that produce only conforming material.
Are there any differences in terms of compliance issues cross-country (or even regions)? Yes and no. In general, there are only minor differences in GMP. However, speaking of auditing, differences
almost always exist.