On- and in-line analysers are used in the framework of PAT (Process Analytical Technology) for controlling and monitoring unit operations in pharmaceutical operations for both batch and continuous manufacturing. The most...
This webinar will introduce the revision to the ISPE Baseline Guide Vol 5: Commissioning and Qualification. The guide was first issued in 2001 and reflective of that time. With emerging markets, changes in the regulatory...
This webinar will discuss the lifecycle of computerized laboratory equipment, with some discussion of the similarities and differences to computer system validation, and the use of quality risk management to right-size...
This webinar provides an overview of new and forthcoming ISPE GAMP ® Data Integrity guidance and real-world experiences on applying data integrity in the field. The speakers will address the following topics: Overview of...
Since April 2017, the European Pharmacopeia allows to produce Water for Injection using other methods than distillation. Meanwhile, the additional water quality "Highly Purified Water" could be found in the Ph. Eur. but...
