This Event has Passed
Friday, September 12, 2014
10:00 AM - 11:00 AM
10:00 AM - 11:00 AM See all dates and Times
http://complianzworld.com/Webinars.aspx?TopicId=398&Sub=Risk-of-Presence-of-Objectionable-Microorganisms-in-Biopharmaceutical-Drug-
Description: The topic of "objectionable microorganisms� has been occupying minds of bio-pharmaceutical manufacturers for some time. The regulations are rather vague on the subject. The US drug regulations in 21 CFR211 state that drug producers must have procedures and appropriate testing to ensure that drug products are free of objectionable microorganisms. Unfortunately, nothing in them helps us to understand what exactly constitutes as an "objectionable microorganism;� the interpretation is left to the organizations themselves to decide.
Course Objective:
This lack of clear guidance from the regulators has not stopped the agency from placing a great burden upon the organizations to ensure medicines they produce do not have objectionable microorganisms. This is clearly evidenced by the recent recall data that show an increase in micro-biologically-related causes.
Course Outline:
• Review of recent recall data
• Definitions of Objectionable Microorganisms
• What is the risk if you find one?
• How bad the microorganism is depends on where you found it
• Examples of Objectionable Microorganisms
• Setting up an applicable risk assessment strategy
Target Audience:
• Manufacturing
• Quality system auditors
• QA directors and managers
• Microbiology analysts and technicians
• Consultants
• Regulatory and Compliance Management
Speaker profile : Henry Urbach
Henry, is the founder of GMP Training, Development and Consulting (GMP TDC) LLC, a New York-based consulting organization serving Life Sciences industries. He has 20+ years of Life Sciences experience having held positions of increased responsibility in Training, QA, and QC Microbiology.
Event Price Tags :
$ 229.00 Single Attendee
$ 799.00 Group – Max 10 Attendees per location
$ 299.00 Access Recorded Version online
$ 399.00 Buy Training CD-DVD
Course Objective:
This lack of clear guidance from the regulators has not stopped the agency from placing a great burden upon the organizations to ensure medicines they produce do not have objectionable microorganisms. This is clearly evidenced by the recent recall data that show an increase in micro-biologically-related causes.
Course Outline:
• Review of recent recall data
• Definitions of Objectionable Microorganisms
• What is the risk if you find one?
• How bad the microorganism is depends on where you found it
• Examples of Objectionable Microorganisms
• Setting up an applicable risk assessment strategy
Target Audience:
• Manufacturing
• Quality system auditors
• QA directors and managers
• Microbiology analysts and technicians
• Consultants
• Regulatory and Compliance Management
Speaker profile : Henry Urbach
Henry, is the founder of GMP Training, Development and Consulting (GMP TDC) LLC, a New York-based consulting organization serving Life Sciences industries. He has 20+ years of Life Sciences experience having held positions of increased responsibility in Training, QA, and QC Microbiology.
Event Price Tags :
$ 229.00 Single Attendee
$ 799.00 Group – Max 10 Attendees per location
$ 299.00 Access Recorded Version online
$ 399.00 Buy Training CD-DVD
