RSSL announces free sterile pharma webinars

Following the launch of RSSL's sterility testing service, this webinar series provides a guide to the complexities around sterile products manufacturing, control, testing and release.

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

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.


What can we expect from the new Annex 1?

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.


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

how biologics have changed the pharma industry

Make an Enquiry