This webinar on objectionable microorganisms will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.
Why Should You Attend:
Due to increased scrutiny by the FDA and other regulatory agencies, companies must now determine how to reduce the risk if they find objectionable microorganisms. This webinar will provide an expert's insight into reducing this risk.
GMPs require that products be free of objectionable microorganisms and it is incumbent upon manufacturers to ensure their products meet these requirements. But just what is an objectionable microorganism? This webinar will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.
Areas Covered in the Webinar:
What is an objectionable microbe?
Pathogens vs. objectionables
Just how objectionable is it?
Consider the risk
Performing a risk assessment
Examples
Who Will Benefit:
All FDA regulated companies will benefit from this webinar - pharmaceutical, biotech, medical device companies and laboratories.
Quality system auditors
QA directors and managers
Information technology managers and personnel
Microbiology analysts and technicians
Consultants
Regulatory and Compliance Management
Microbiologists
Instructor Profile:
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.
Why Should You Attend:
Due to increased scrutiny by the FDA and other regulatory agencies, companies must now determine how to reduce the risk if they find objectionable microorganisms. This webinar will provide an expert's insight into reducing this risk.
GMPs require that products be free of objectionable microorganisms and it is incumbent upon manufacturers to ensure their products meet these requirements. But just what is an objectionable microorganism? This webinar will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.
Areas Covered in the Webinar:
What is an objectionable microbe?
Pathogens vs. objectionables
Just how objectionable is it?
Consider the risk
Performing a risk assessment
Examples
Who Will Benefit:
All FDA regulated companies will benefit from this webinar - pharmaceutical, biotech, medical device companies and laboratories.
Quality system auditors
QA directors and managers
Information technology managers and personnel
Microbiology analysts and technicians
Consultants
Regulatory and Compliance Management
Microbiologists
Instructor Profile:
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.
