Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
Instructor:
Henry Urbach
Product ID: 702634
- Duration: 60 Min
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
- Validation
- Manufacturing
- Quality system auditors
- Warehouse managers
- Facilities/maintenance
- Regulatory and compliance management
Henry Urbach, 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 GMP Training 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 for major pharmaceutical and biotechnology organizations. He is a dynamic speaker specializing in FDA and ICH compliance. He is a Certified Quality Auditor. 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.
Topic Background:
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.
More Training By Experts
- Microbiological Risk: Do I Really Need to Test Raw Materials for Microorganisms
- You Found an Objectionable Microorganism, Now What? Risk of presence of Objectionable Microorganisms in Biopharmaceuticals
- Creating Effective SOPs for Regulatory Compliance
- Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?
- Creating FDA-compliant cGMP Training Program
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund 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. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
