Chip Bennett, PMP & Nathan Temple
his webinar discusses the current industry transition of principle ownership of process manufacturing performance verification from Quality/Validation to Engineering – a transition that empowers both Engineering and Quality with the tools to deliver true Quality by Design, resulting in improved product quality (patient safety) and increased speed to market.
This webinar will discuss how to get the most benefit from a QRM program so that it delivers its full potential as a powerful tool for decision making, prioritisation, efficiency, continuous improvement, training and knowledge management.”
This webinar introduces the concept of robotic process automation (RPA) and discusses how the technology may be used within a GAMP® framework to support both non-GxP and GxP processes.
This Educational Session will cover a risk-based approach to a cleaning and disinfection program and new recent case studies in contamination control. Details will be provided on how to follow a risk-based approach for cleaning and disinfection using good science.
This presentation deals with Clean Room Contamination Control by Computational Fluid Dynamic Simulation.
Dr. Lucia Ceresa
The webinar will cover:
• Relevant guidelines and validation parameters
• A successful approach for the validation of an ATP Bioluminescence based Rapid Microbial Method
• A well-defined method of stressing microorganisms to investigate a “worst case approach”
This webinar will set out to investigate the key points for consideration in maintaining a strategic approach to Data Integrity (DI) in the Microbiology Laboratory. With focus on the requirements for compliance, the critical factors that impact DI compliance, electronic data and software compliance, and the impact of the human element on DI compliance.
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