10:00 Warm-up
1. FDA & CFR – characteristics of the organization & regulations.
2. 21 CFR Part 11 – familiarization with the modules.
3. 21 CFR Part 11 – requirements necessary to meet compliance.
4. 21 CFR modules – description, requirements.
5. 21 CFR Part 11 in practice - how RADWAG balances meet the requirements.
6. hands-on with the balance – measurements, reports, printouts, Audit Trail
14:00 Conclusion and Q&A session
You will learn what is involved in a regulation that electronic signature of weighing reports
You will see how to comply with the 21 CFR Part 11 regulation
You will experience how easy it is to implement electronic signature assumptions using a RADWAG balance
Trainers
Radosław Wilk, M.Sc., eng
Laboratory Product Manager, Senior Product Trainer. He is a Laboratory Product Manager as well as a Senior Product Trainer at RADWAG. He has been working for RADWAG for over 17 years and during this time has been responsible for many different products in laboratory family as a Product Manager. He specializes in laboratory solutions which means not only weighing in the laboratory but also all of the regulations related to laboratory e.g. legal metrology or validations/ qualifications.