Establishing Compliance of Batch SCADA Systems with FDA CGMP 21 CFR Part 11

The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

The alterations are the result of an agency review of findings from a clinical trial, and data from required postmarket studies.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Artificial intelligence, among other technological advances, is pushing innovation boundaries.

Treatments for autoimmune diseases, multiple cancers, and skin blistering have been recommended for marketing approval.