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PDA Comprehensive Course Series Addresses Need for Aseptic Process Training
Date:1/10/2014

BETHESDA, Md., Jan. 10, 2014 /PRNewswire-USNewswire/ -- No pharmaceutical manufacturer wants to be greeted by a Warning Letter from the Food and Drug Administration that reads like any of these actual letters.

  • "…monitoring program is not adequate to ensure the environment is suitable for aseptic   processing of sterile product."
  • "…troubling lapses, including discolored HEPA filters with chipped paint."
  • "…multicolored coalescing droplets."
  • "…clumps of dark material."

(Logo: http://photos.prnewswire.com/prnh/20130226/DC66667LOGO)

However, many firms are cited for problems with their aseptic processes because the FDA places a major emphasis on aseptic processing technology as part of the agency oversight responsibility, according to Bob Dana, Senior Vice President of Education for the Parenteral Drug Association, PDA.

Gaining Skills in Risk-Free Training at PDA Training and Research Institute
Couple those warnings with the fact that having adequate knowledge and skills of all the elements of a good aseptic process can be daunting.   Further, every year, new people come into the field either in their first job or on a new assignment with responsibilities for aseptic processing.

So how can individuals responsible for aseptic processing or managers who are in charge of the operation improve their knowledge?   Each year, PDA offers a series of intensive lab and lecture courses in Asep
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SOURCE Parenteral Drug Association
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