DUBLIN–(BUSINESS WIRE)–The “Risk-based Computer System Validation; Reduce Costs and Avoid 483s (ONLINE EVENT: August 6-7, 2025)” has been added to ResearchAndMarkets.com’s offering.
This highly interactive two-day course uses real-life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing and maintaining computer systems in regulated environments.
Key Points
- Focuses on compliance with Part 11 and Annex 11, covering SOPs and software qualification.
- Addresses industry standards for data security and electronic records.
- Learn to decrease software implementation times using a 10-step risk-based approach.
- Recognises recent FDA inspection trends to streamline documentation processes.
- Participants will draft a compliant Data Privacy Statement as per GDPR.
- Designed for professionals in healthcare, clinical trials, biopharma, and medical devices.
Why should I read this?
This article highlights an invaluable course for anyone tangled in the world of computer systems in regulated sectors. If you’re keen to cut costs and avoid those dreaded 483s, this is your jam! It’s a savvy way to ensure compliance while actually saving money—who doesn’t want that?
