Hosted by Tim Sandle this complimentary webinar series 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.



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.

Webinars

Sterility Testing - Overcoming Difficult Products

Learning Outcomes:

• The difficulties associated with sterility test method validation in general
• Practical approaches for products where pharmacopoeial methods cannot be readily applied
• Examples: Mercurial compounds, antibiotics, turbid samples, medical devices, oily samples
• Some supporting aspects for sterility test method validation
• Essential validation documentation
• Guidance on training requirements

To view this webinar on demand please click here.

To download the associated Whitepaper "Sterility Testing - Overcoming Difficult Products" please click here.

Best Practices for Cleaning and Disinfection

Learning Outcomes:

• Global guidelines for disinfection in cleanrooms: EU GMP (& draft Annex 1), USP <1072>, FDA aseptic processing guidance, PIC/S
• Importance of cleaning and disinfecting
• How to select and use disinfectants effectively
• Points for success
• Practical approach to disinfectant validation
• Legal requirements for disinfectants

To view this webinar on demand please click here.

To download the associated Whitepaper "Best Practices for Cleaning and Disinfection" please click here.

COVID-19 Prevention Measures for Those Working in GMP Pharmaceuticals and Healthcare Facilities

Learning Outcomes:

• What is coronavirus?
• Relative risks
• Transmission vectors
• Temperature and general hygiene assessments
• PPE – what works (and what doesn’t)
• Guidance for working in cleanrooms
• Risks of coronavirus in relation to HEPA filters
• Which are the best disinfectants to kill coronavirus?

To view this webinar on demand please click here.

To download the associated Whitepaper "Considerations of COVID-19 Prevention Measures for those working in GMP Pharmaceuticals and Healthcare Facilities" please click here.

EU GMP Annex 1 - Implications for Sterile Products Manufacture

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

To view this webinar on demand please click here.

To download the associated Whitepaper "EU GMP Annex 1: The New Draft and the Implications for Sterile Products Manufacturing" please click here.

Reviewing Sterile Products - Examining the Factors Required for Release

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 view this webinar on demand please click here.

To download the associated Whitepaper "Reviewing Sterile Products - Examining the Factors Required for Release" please click here.

Investigating Sterility Testing Failures

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 view this webinar on demand please click here.

To download the associated Whitepaper "How to Investigate Sterility Test Failures" please click here.

Best Practices in Environmental Monitoring

Learning Outcomes:

• What environmental is and what it is not
• Understand the objectives of environmental monitoring as well as aspects to consider with EM methods
• Understand contamination sources and risks and how to profile microbial contamination
• Rapid microbiological methods
• Core elements of the EM programme – what, when and how often?
• Data and CAPA

To view this webinar on demand please click here.

To download the associated Whitepaper "Best Practices in Environmental Monitoring" please click here.

Related Services

• Sterility Testing