Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing
Instructor:
Henry Urbach
Product ID: 703474
Training Level: Intermediate
- Duration: 90 Min
Why Should You Attend:
Contamination issues lead to lengthy investigations and costly recalls. In recent years there have been a number of FDA actions related to contamination issues. Even the largest pharmaceutical multinationals are not immune, as evidenced by recent recalls of drug products. Ensuring the control of contamination within your facility is paramount to the survival of your organization. Creating an effective Contamination Control program is a key to minimizing these problems and ensuring that your company does not end up as the next TV or newspaper headline.
This webinar will discuss various sources of contamination including aseptic processing, clean room classifications and alert/action limits. It will also provide an overview of an effective Environmental Monitoring (EM) program.
Areas Covered in the Webinar:
- Taking ownership for contamination prevention
- Sources of microbial contamination
- Controlling/minimizing microbial ingress
- Methods of combatting microbial contaminants
- Limitations of surveillance programs
- System approach to Microbial control
- Controlling contamination
Who Will Benefit:
Managers, supervisors and general staff working in the following functional areas:
- Quality Assurance
- QC Microbiology Laboratory
- Aseptic Processing areas Cleaning Services
- Manufacturing
- Facilities
- Facility/Process Design Engineering
Henry Urbach
Principal, GMP TDC LLC
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 and implementing CGMP compliance and quality systems training, 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.
More Training By Experts
- Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
- 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?
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).
