Webinar Series - Manufacturing Sterile Pharmaceuticals

This RSSL webinar series, hosted by Dr Tim Sandle, will guide you through the complexities around sterile products manufacturing, control, testing and release

This complimentary RSSL webinar series following the launch of RSSL's sterility testing service, will guide you through the complexities around sterile products manufacturing, control, testing and release.

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.

The 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.

Webinar: EU GMP Annex 1 - Implications for sterile products manufacture
Wednesday 1 April 2020 14:00 – 15:00 (BST)

Learning Outcomes
  • Understand the major updates to the latest draft of EU GMP Annex 1 for sterile products manufacture and how they differ to the current guidance
  • Learn how the key changes will impact the control and release of sterile products and gain advice on how to get prepared before the regulation becomes final
  • Gain an insight into the elements required for a contamination control strategy
  • Become familiar with the importance of quality risk management in relation to sterile products

Please note: This webinar is now fully subscribed. A recording will be shared after the webinar for those wishing to view it.

Webinar: Reviewing sterile products - Examining the factors required for release
Wednesday 6 May 2020 14:00 – 15:00 (BST)

Learning Outcomes
  • Gain an insight into the critical microbiological quality attributes required for the manufacture of sterile products, including bioburden and endotoxin control
  • Assess the physical control factors to support sterile products manufacture, from sterile filter integrity testing to cleanroom certification
  • Understand the types of controls required for fill and finish activities, in line with current GMP
  • Review a holistic approach for batch release based on ensuring there is an assurance of sterility

To register for the webinar please click here

Webinar: Investigating sterility test failures
Thursday 4 June 14:00 – 15:00 (BST)

Learning Outcomes
  • 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

To register for this webinar please click here

Expert Webinar Speaker
Dr. Tim Sandle

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.

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