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
Introduction to mycoplasma and cell product risks
Mycoplasma species are the most common contaminants in cellular therapies. This webinar introduces Mycoplasmas and outlines the risks they present and the remediation strategies required to control the microorganisms.
Learning outcomes:
- Risks posed to cellular products
- Sterile filtration challenges
- Surface adherence challenges
- Sources of contamination including association with cell culture reagents
- Remediation strategies, including donor material assessment
- Regulations
To view this webinar on demand please click here.
Sterility assurance in cell therapy products
Cellular therapy products represent a new wave in pharmaceuticals and include cellular immunotherapies, cancer vaccines and other types of both autologous and allogeneic cells for certain therapeutic indication. While the products are novel, sterility assurance concerns remain fundamental.
Learning outcomes:
- Sterility assurance principles
- Sterility testing
- Rapid microbiological methods
- Environmental monitoring
- Facility, equipment, raw materials, test system, and personnel
- Control of the collection, processing, packaging, and distribution of cell products
To view this webinar on demand please click here.
Water systems – microbial monitoring and qualification strategy
Water is fundamental to pharmaceutical processing, from cleaning to use as an ingredient. Therefore, water system control is of fundamental importance. This webinar looks at best control and monitoring practices for pharmaceutical water systems.
This webinar covers:
- Water system – design and control
- Biofilms
- Microbiological concerns
- Microbiological risks
- Risk assessment
- Microbiological tests and acceptance criteria
- Why do failures happen?
To view this webinar on demand please click here.
Spores in my cleanroom – remediation and disinfection strategies
Spores, both bacterial and fungal, present problems for contamination control. Spores are very resistant to conventional cleaning and disinfection, with bacterial spores presenting a resistance problem and fungal spores presenting a particular risk in terms of dispersal.
Learning outcomes:
- Overview of spores - Bacterial and Fungal
- Risks posed by spores to pharmaceutical operations
- Sporicidal disinfectants: Selection and concerns
- Issue of disinfectant / sporicide resistance
- Sources of spores
To view this webinar on demand please click here.
People in the cleanroom – contamination risks, clothing and behaviours
There are different sources of microbial cleanroom contamination. However, the most common source is with people, both in terms of what is carried on the human body and how people behave.
People risks include:
- Skin flakes and oil
- Cosmetics and perfume
- Spittle
- Clothing debris (lint, fibres etc.)
- Hair
- Touching and transfer
- Rapid movements
- This webinar considers strategies to minimise people related contamination, including a review of gowning, gloves and masks, disinfection, behaviours and training.
To view this webinar on demand please click here.
Cleanroom design and certification
Cleanrooms provide the structure within which pharmaceutical processing takes place, yet many in production and quality departments are not familiar with the design, operational and certification requirements.
The revised Annex 1 sees a considerable expansion in scope when it comes to cleanroom design. This webinar outlines the current thinking in the subject.
Learning outcomes:
- To understand the essentials of cleanroom design to achieve contamination control and compliance:
- filtration, air exchanges, air movement, pressure differentials and construction
- To consider the certification to cleanrooms according to ISO 14644 and EU GMP best practices, including assessments of particles, microorganisms, and appropriate physical parameters
To view this webinar on demand please click here.
Essential elements of a contamination control strategy
A contamination control strategy is a system that considers all the integral elements of pharmaceutical product manufacturing. This is best achieved using quality risk management principles and supporting risk assessments for contamination control and monitoring (detectability of contamination event). This webinar presents the fundamentals of such a strategy.
Fundamentals covered:
- Microbial contamination
- Cleaning and disinfection
- Sterility assurance
- Facility design
- Chemical and particle contamination
- Other forms of contamination that can arise from mix-ups, damaging primary or secondary packaging, distribution problems, and environmental fluctuations
The need for a contamination control strategy will be a core part of the revision to EU GMP Annex 1 and this webinar will provide advice on how to meet this requirement.
To view this webinar on demand please click here.
Quality risk management for pharmaceuticals
Learning outcomes:
- Understand the fundamentals of risk management
- Discover the tools and techniques for risk management
- Appreciate the importance of a scientific and data driven approach to risk management
- Gain insight through considering case studies in risk management
- Learn how risk management can go wrong
To view this webinar on demand please click here.
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.
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.