Location: OnlineJoin the STERIS Life Sciences team for a wonderful learning opportunity during our upcoming webinar.
Why attend the presentation:
To understand how to develop an adequate risk-based assessment for contamination control and sterility maintenance to ensure compliance with international regulatory guidelines. Also, to understand what Draft Annex 1 requirements are considered arbitrary vs. imposed.
What will be covered:
Contamination control and sterility assurance maintenance are critical focus areas in the (bio)pharmaceutical and medical device industries. However, contamination control in sterile and non-sterile pharmaceutical manufacturer are amongst the top 10 most observed deficiencies by the FDA since 2012. The situation in Europe is not any different based on recent UK MHRA deficiencies found, and the noncompliance reports handed out by European Inspectors. Finally, “lack of sterility assurance” is one of the major recall reason for the sterile pharmaceutical industry which reflect inadequate manufacturing and contamination control practice or packaging integrity maintenance. The goal of this presentation is to support manufacturers to understand the draft Annex 1 requirements and their impact on the global manufacturer. The discussion will deep dive on each technology such as cleaning and disinfection, sterilization and including utilities microbial contamination control program. Despite the difference between regulatory requirements, the presentation will share how to develop adequate risk-based assessment to support a harmonized process for contamination control and sterility maintenance to ensure compliance with international regulatory guideline (such as Japan, USA, Europe, WHO and PIC/S). Lastly, we will discuss on the draft annex 1 requirements that are considered as arbitrary imposed regarding contamination control and sterilization process.
Who will benefit:
Duration: 1 hour