Applying FMEA risk assessment to a sterility testing isolator

Date: Thursday, 21 March 2019 | Time: 10:00 AM PDT, 01:00 PM EDT | Duration: 60 Minutes
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Avoidance of hazards and assessment of risk have long been part of the manufacture of pharmaceuticals and healthcare products. A high-quality drug product must be free from contamination and reliably deliver the intended therapeutic dose as stated on the label. To achieve this, manufactures have always needed to be mindful of risk and to undertake proactive risk assessments. This webinar discusses how the risk analysis tool of Failure Modes and Effects Analysis (FMEA) can be applied. This is based on a case study of a sterility testing isolator.
Risk Analysis Tool of (FMEA)
Instructor: Tim Sandle
Product ID: 508790
Objectives of the Presentation
  • The importance of risk assessment
  • The basis of Failure Modes and Effects Analysis
  • The advantages and disadvantages of Failure Modes and Effects Analysis
  • Hazard identification and risk scoring
  • How isolators work
  • Using Failure Modes and Effects Analysis to identify weaknesses with a sterility testing isolator
  • Reducing risks and correcting potential issues
Why Should you Attend
The webinar will be of interest to two groups - those who are interested in risk analysis and wish to learn about risk assessment tools, such as a structured approach like FMEA; and to those who are interested in isolators as a means of achieving contamination control (in this case using the example of a sterility testing isolator). When isolators are not assessed adequately for risks, this can lead to false sterility test positives. The focus is on using an FMEA risk assessment to address isolator weaknesses.

Areas Covered
  • Risk management and GMP expectations
  • The origin of FMEA
  • Different types of FMEA
  • How isolators work
  • Identifying operational concerns with isolators
  • Risk scoring
  • Revisiting risk assessments and implementing corrective actions
  • Documenting and reporting risk assessments
Who will Benefit
  • Engineers
  • Process staff
  • Quality control
  • Quality assurance
  • Microbiology
Topic Background
Much of the effort of risk assessment is directed towards contamination control or ensuring a process, with the required equipment, runs as intended. The objective of risk management, in the context of contamination control, is to systematically assess, control, and review manufacturing processes in terms of priorities, and subsequently develop appropriate measures to control risks. One tool for this task is failure modes and effects analysis (FMEA), which is a procedure for the analysis of potential failure modes within a system for classification by severity or determination of the effect of failures on the system. Sterility testing isolators, when they go wrong, can lead to false sterility test failures, which are costly to businesses. The webinar describes how FMEA can be applied to sterility test isolators as a preventative measure.
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Instructor Profile:
Dr. Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The University of Manchester School of Pharmacy. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals.

Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle's current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.

In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of eleven editorials boards for scientific journals.

Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.
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