Read Frequently Asked Questions
Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
This 60-minute webinar will show how you can design a robust microbiological audit program for pharmaceutical and biopharmaceutical product manufacturing, that effectively assesses your facility and that of your supplier to ensure your facilities and products are free from microbial contamination.
Why Should You Attend:
The risk of non-compliance related to microbiological causes is too great, in terms of fines, potential law suits, loss of consumer confidence, and ultimately, the bottom line. This means that biopharmaceutical manufacturers must prove that their facilities and products are free from contamination.
This webinar is designed to help organizations understand that preventing microbial contamination is the responsibility of everyone in the organization, and that everyone must play a part in it. Attendees will learn how to create a robust inspection program that includes auditing for potential sources of microbial contamination.
Areas Covered in the Webinar:
- What do regulations say about the subject?
- Sources of contamination
- Preventing contamination
- Controlling contamination
- What about the suppliers?
- Everyone has a role in contamination control
Who Will Benefit:
This training webinar has been designed for the following personnel in pharmaceutical, biopharmaceutical and medical device companies:
- Quality assurance personnel
- Quality control personnel
- Microbiology professionals
- Quality system auditors
- Warehouse managers
- Regulatory and compliance management
Henry Urbach is a founder of GMP Training, Development and Consulting (GMP TDC) LLC, a New York-based consulting organization serving life sciences industries. He has over 20 years of life sciences experience having held positions of increased responsibility in training, QA, and QC microbiology. His experience includes managing GMP compliance and quality systems training, implementing a training program as part of a post-regulatory action remediation, and developing an environmental monitoring training program. He is a dynamic speaker specializing in FDA and ICH compliance. He is a Certified Quality Auditor (CQA). His technical education is further complemented by his BA degree in biology and MBA, which provide a scientific and business insight. He is a member of the ASTD, ASQ, and GMP TEA, a national organization of life sciences training professionals.
In recent years the number of recalls related to microbiological causes has been on the rise. FDA regulations, 21 CFR 210 and 211, mandate that biopharmaceutical products must be pure, safe and effective. To comply with these regulations each organization must create a robust inspection program that includes auditing for potential sources of microbial contamination.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
For substitution, please email email@example.com or call +1-650-620-3937.
This training hasn't been reviewed yet.
Microbiological Risk: Do I Really Need to Test Raw Materials for Microorganisms Objectionable Microorganisms: Considering the Risk Creating Effective SOP for Regulatory Compliance Why I should test raw materials for microbial presence: Microbiological and business risks