PART I

The first part of the webinar explains the microbiological quality control of drugs and the quality assurance during production, which are most relevant to ensure a safe product to the patient. The microbiological requirements are laid down in various regulations and guiding documents.

This broadcast will give an overview of the most relevant tasks of the microbiological quality control unit in pharmaceutical industry. The general methods such as sterility test, bioburden, endotoxin, and environmental monitoring are presented to give the audience an idea about hygiene and microbiological quality control tasks.

Part II

Learn in the second part of the presentation about data integrity as well as connectivity requirements for a modern laboratory balance and find out how to be compliant with the latest guidelines for the pharmaceutical industry.

Get to know how to achieve data integrity, minimize risk and the potential for FDA violations, and how digital workflows can be supported by technology like the Sartorius Cubis® II lab balance.
 In addition to that important news for the pharmaceutical industry will be highlighted. The new Chapter 2.1.7 of the European Pharmacopoeia will be compared with the United States Pharmacopeia Chapter 41, underlining the differences and discussing software solutions to ensure compliance with both chapters.