Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing

Instructor: Henry Urbach
Product ID: 703474
Training Level: Intermediate
  • Duration: 90 Min
This webinar will enable participants to understand sources of contamination and to investigate various contamination issues in the biopharmaceutical manufacturing of sterile and non-sterile products. Learn how to create an effective Environmental Monitoring (EM) program.

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: May-2017

Training CD / USB Drive

$349.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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
Instructor Profile:
Henry Urbach

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.

Follow us :
Medical Device Summit 2020
The Veterinary Drug Approval Process and FDA Regulatory Oversight

Refund Policy

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.

If you have any concern about the content of the webinar and not satisfied 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 customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

Product Reviews Write review

This was a solid basic webinar on microbial contamination sources and control programs. The instructor was well spoken, and the presentation covered a good amount of material in the time given. I will definitely keep the slides and refer back to them in the future. Overall this was a webinar that I would recommend.
- Anonymous

Best Sellers
You Recently Viewed
    Loading