This webinar is part of a complimeny series provided by RSSL and hosted by Dr Tim Sandle.
These webinars are designed to guide you through the complexities around sterile products manufacturing, control, testing and release.
RSSL Webinar: Investigating Sterility Test Failures
Thursday 4 June, 14.00 - 15.00 (BST)
Learning Outcomes of this webinar:
Sterile pharmaceutical preparations - injections, infusions and pharmaceutical forms for application on eyes and on mucous membranes - are expected to be efficacious and safe.
The safety includes being sterile and free from microbial toxins and visible particles. However, achieving sterility is not straightforward, requiring a series of manufacturing controls and sterilisation steps.
Assurance of sterility is obtained through an assessment of environmental controls, staff training, sterile components, environmental monitoring, and the end product sterility test. This means sterile products manufacturing itself is a continuum that stretches from development to manufacturing, to finished product, to marketing and distribution, and to utilisation of drugs and biologics.
These webinars are designed to cover the critical steps, focusing on the requirements of Good Manufacturing Practice (GMP) and the essential elements needed to develop a robust sterility assurance system and contamination control strategy.
About the speaker:
Dr. Tim Sandle has over twenty-five years’ experience of microbiological research and biopharmaceutical processing. He is a member of several editorials boards and he has written over six-hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle works for a pharmaceutical manufacturer in the UK, and is a visiting tutor at both the University of Manchester and UCL.
These webinars are designed to guide you through the complexities around sterile products manufacturing, control, testing and release.
RSSL Webinar: Investigating Sterility Test Failures
Thursday 4 June, 14.00 - 15.00 (BST)
Learning Outcomes of this webinar:
- Understand the immediate actions to be taken in the event of a sterility test failure
- Review the focal points for the laboratory failure investigations, from reviewing training to isolator controls
- Find out how to construct a road map for process failure investigations, from filter controls to personnel interventions
- Learn how to reach an outcome and to set effective follow-up corrective and preventative actions
Sterile pharmaceutical preparations - injections, infusions and pharmaceutical forms for application on eyes and on mucous membranes - are expected to be efficacious and safe.
The safety includes being sterile and free from microbial toxins and visible particles. However, achieving sterility is not straightforward, requiring a series of manufacturing controls and sterilisation steps.
Assurance of sterility is obtained through an assessment of environmental controls, staff training, sterile components, environmental monitoring, and the end product sterility test. This means sterile products manufacturing itself is a continuum that stretches from development to manufacturing, to finished product, to marketing and distribution, and to utilisation of drugs and biologics.
These webinars are designed to cover the critical steps, focusing on the requirements of Good Manufacturing Practice (GMP) and the essential elements needed to develop a robust sterility assurance system and contamination control strategy.
About the speaker:
Dr. Tim Sandle has over twenty-five years’ experience of microbiological research and biopharmaceutical processing. He is a member of several editorials boards and he has written over six-hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle works for a pharmaceutical manufacturer in the UK, and is a visiting tutor at both the University of Manchester and UCL.
