This webinar will focus on difficulties and hurdles faced during data integrity systems implementation, actions taken and success stories. The focus of the webinar will be
Risk management approach to overcome data integrity risks , data governance framework , quality culture of an organisation, regulatory requirements ,citations and how to prevent such observations.
The Webinar will cover the discussion about Barrier Systems like Isolators. Barrier Systems like Isolators are the first choice from the regulatory authorities to prevent the direct access from the operators to the aseptic critical zone. I
This Educational Session will provide an overview of microbiology principles in steam sterilization and application, as well as autoclave Performance Qualification, regulatory expectations and cGMPs. The presentation will highlight common questions and hot topics in industry to demonstrate the practical application of understanding steam sterilization.
Dr. Tim Sandle
The webinar focuses on the likely occurrences of false positives and the areas for consideration including the sterility test environment, operator technique, consumables and reagents, and what might have caused a failure within the production environment, including issues relating to aseptic practice, sterilisation and barrier technology.
This webinar will help in developing better understanding of Information Security in today’s context. This session will focus on enhancing knowledge on CIA triad.
Learn how to navigate the complexity of cybersecurity within Pharma 4.0 for IT and OT environments according to GAMP 5 best business practices.
Deep Dive into the development of cold WFI production, Qualification and Regulatory Compliance
This webinar will cover : FDA initiatives for quality Statistical Quality Control Statistical Process Control Identify and describe causes of variation Control charts and Control limits Process capability and process