Fungal Contamination and Pharmaceutical Products Recall

Duration: 60 Minutes
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Over the past decade, the number of pharmaceutical product recalls due to fungi has increased significantly, with many different product groups affected. Data suggests a link between product contamination and the process environment. A key concern is a lack of knowledge, even among microbiologists, about identifying fungi and understanding their origins. This webinar will explain different types of fungi, risks to products, guidance on identification, and a focus on remediation measures to remove, eliminate and to prevent fungi.
Pharmaceutical Product Recalls to Fungi
Instructor: Tim Sandle
Product ID: 509707
Objectives of the Presentation
  • To learn about fugal risks
  • To appreciate the extent of pharmaceutical product recalls relating to fungi
  • To understand which types of medicinal products are most at risk
  • To learn about the common types of fungi associated with cleanrooms
  • To understand the main points of contamination
  • To learn about monitoring techniques
  • To learn about good disinfection practices
  • To understand other remediation activities
Why Should you Attend
In this webinar speaker will examine the risks posed by fungi to pharmaceutical products and has emphasized how this is an issue of growing importance (as seen by the extent of product recalls relating to fungal contamination). The webinar has further considered where fungi pose a risk within the manufacturing process and also to argue that recalls relating to fungal contamination can be reduced through improved cleanroom design; risk assessment; and developing greater specialism’s within quality control departments in order to be able to characterize, identify and to trace fungi. This way, the risks posed by fungi to pharmaceutical processes should receive the level of attention necessary, especially in light of the potential for certain products to become contaminated.

Areas Covered
  • Trends in pharmaceutical product recalls due to microbiological and fungal contamination
  • FDA and other regulatory concerns
  • Risks posed by fungi in cleanrooms
  • Types of fungi
  • Environmental monitoring methods
  • How to kill fungi
  • How to identify different types of fungi
  • How to design facilities to avoid fungal contamination
  • Good remediation practices
Who will Benefit
  • Production managers
  • Microbiologists
  • Quality Assurance
  • Production staff
  • Maintenance / engineer staff
  • Medical staff
  • Pharmaceuticals – sterile and non-sterile
  • Medical devices
  • Biotechnology
  • Healthcare
  • Academia
$375
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  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
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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