Risk of Objectionable Microorganisms in Bio-Pharmaceutical Manufacturing
01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and Live Webinar
"Listen from Carl Patterson "Creating a QC Lab function where none had existed previously (Bioserv)""
Objectionable microorganisms are considered, if discovered, harmful to the patient. By identifying and controlling these microorganism and putting the appropriate controls place early in the pharmaceutical manufacturing or medical device manufacturing process problems in the patient can be prevented. This webinar will review the regulations pertaining to objectionable microorganisms, agency expectations, methods to identify objectionable microorganisms, interpreting results, and controls to put into place. By knowing, where, when, why, and how objectionable microorganisms exist, harmful consequences to the patient can be prevented.
• Definition of objectionable microorganisms
• Regulations pertaining to objectionable microorganisms
• Identifying objectionable microorganisms
• Tests to determine objectionable microorganisms
• Sources of objectionable microorganisms
• Actions to reduce objectionable microorganism
• And much, much more…
Who will Benefit
• QA personnel,
• QC personnel,
• Manufacturing personnel,
• Auditing personnel
Industries who can attend
This 60 minute online course is intended for professionals in the Pharmaceutical and Biopharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.