Understanding current CFR 21.11 and data integrity requirements
The US FDA and European Commission have defined regulations relating to the submission of electronic records in lieu of paper documents, for submission, inspection, and archiving purposes. When ageing analytical equipment is to be replaced 21CFR Part 11 and EU Annex 11 are also topics of discussion. Common questions from pharma and biopharmaceutical manufacturers include: is the new technology compliant with auditor expectations? Can we get the right data saved the right way in the right place? Can we use USB devices?
These are just some of the questions that arise—often with concern or even panic—due to the large workload that may go along with the implementation of equipment.
During this webinar, we discuss what is actually required and where we might burden ourselves with the misinterpretation of regulatory requirements. We also discuss the ‘new’ term data integrity and how the right digital records can help us comply.
Sievers TOC Analyzers are designed to help increase efficiency while complying with data integrity guidance. In this webinar we will discuss how Sievers instruments can help you comply and how the Sievers Lean Lab solution can help make your lab testing for USP and compliance faster, more efficient, and more reliable.
Daniel Kellner-Steinmetz, EMEA Application Lead UPW/CV, SUEZ
Daniel Kellner-Steinmetz is the EMEA Applications Specialist for SUEZ. He has eight years of experience in the Quality, Manufacturing, and Training areas of the pharmaceutical industry. Most recently he served as the Global Product Quality Lead for several commercial products at Shire (formerly Baxter) in Vienna. Daniel holds a Bachelor of Science in Biomedical Engineering.
Analytical techniques, Big Pharma, Biopharmaceuticals, Bioproduction, Clinical Development, Data Analysis, Drug Manufacturing, Environmental Monitoring, Good Manufacturing Practice (GMP), HPLC, Manufacturing, Personalised medicine, Process Analytical Technologies (PAT), Production, QA/QC, Regulation & Legislation, Research & Development (R&D), Single Use, Technology