Burkholderia cepacia - Risks in Context for Non-Sterile Pharmaceutical Products

Duration: 60 Minutes
flat 50% off on this webinar
Burkholderia cepacia complex (BCC) organisms can survive or multiply in a variety of non-sterile and water-based products because it is resistant to certain preservatives and antimicrobial agents. This makes the organism a risk in terms of non-sterile aqueous products. Detecting BCC bacteria is also a challenge and requires validated testing methods that take into consideration the unique characteristics of different BCC strains. This webinar discusses where the organism may be found, how to detect it and what to do if it is present in the manufacturing environment.
Burkholderia cepacia
Instructor: Tim Sandle
Product ID: 505827
Objectives of the Presentation
  • The origins of Burkholderia cepacia in pharmaceuticals and healthcare
  • Risks to patients
  • The link to pharmaceutical product recalls
  • The need to design a testing regime
  • The use of rapid methods for detection
  • Strategies for method validation
  • The importance of a holistic contamination control strategy
Why Should you Attend
Drug manufacturers of non-sterile, water-based drug products have seen recent product recalls due to Burkholderia cepacia complex. Regulatory agencies expect pharmaceutical manufacturers to be testing environments, water and products for the organism and putting remedial measures in place. In order to test effectively, microbial methods need to be suitably qualified. The qualification of methods is challenging. Attend this webinar to learn more about this microorganism of concern, and to learn about its origins, risk factors, means of mitigation and methods of detection.

Areas Covered
  • What is Burkholderia cepacia?
  • Patient risks
  • Product recalls
  • Where Burkholderia cepacia is found in the pharmaceutical environment?
  • How to test for the organism, using conventional and rapid methods
  • How to qualify methods
  • Remediation strategies should contamination occur
  • The need for a contamination control strategy
Who will Benefit
  • Quality assurance
  • Quality control
  • Production managers
  • Medical staff
  • Infection control
  • Microbiologists
  • Engineers
  • Lecturers
  • Production managers
  • Production staff
  • Maintenance / engineer staff
  • Pharmaceuticals - sterile and non-sterile
  • Biotechnology
  • Healthcare
  • Academia
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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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