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).
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.
Learning Objectives:
To learn about fungal 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:
This webinar explains the risks caused and the extent of pharmaceutical product recalls relating to fungi.
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 specialisms 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
Instructor Profile:
Dr. Tim 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.