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."
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 Aseptic Processing, and each year the classes fill up fast. Some seats are still available in the first session, scheduled for February 3-7, 2014.
Participants attend the first week, then come back a month later for the second week. They receive the opportunity to learn from industry experts in the classroom, and then practice their skills risk free in PDA's renowned Training and Research Institute labs in Bethesda, Maryland.
"This is a comprehensive, hands-on laboratory and classroom training program," says Dana.
"You will learn how to pull all the pieces together into one operation so that you have an overall improved process and finished product."
The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more nearly 10,000 members worldwide.
CONTACT: Amelia Townsend, 1-301-656-5900 ext. 153, firstname.lastname@example.org
Video with caption: "Whether you need hands-on training in core subjects such as Aseptic Processing or need to understand how to do a proper visual inspection, you'll find what you need in PDA's renowned Training and Research Institute...where excellence begins." Video available at: http://www.youtube.com/watch?v=V4SXVuP72co&feature=share&list=PLR8sZfy5c4UpBXFT4yeHSvg3UCeJgvlwB
SOURCE Parenteral Drug Association