ComplianceOnline

Auditing for Microbiological Aspects in Pharmaceutical and Biopharmaceutical Manufacturing

Instructor: Carl Patterson
Product ID: 705547
Training Level: Intermediate
  • 18
  • January 2018
    Thursday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 60 Min

Live Online Training
January 18, Thursday 10:00 AM PST | 01:00 PM EST | Duration: 60 Min

$129.00
$199.00 (35%)
Save $70.00
One Dial-in One Attendee
$529.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Super Deal - Get CD/USB Drive Free!

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 48 hrs after completion of Live training

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 after completion of Live training

Combo Offers

Live + Recorded Version

$349.00

Live + Training CD/USB

$449.00

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

Microorganisms can be found in any aspect of pharmaceutical and, especially, biopharmaceutical manufacturing. Understanding where to look for microorganism and how these are introduced into your process will provide success when being reviewed by an auditor. It is not enough to identify microorganism in your process, but to understand, how, where, when, and why the microbes are in your process. These are questions regulatory auditors will ask when your facility is being inspected.

Why Should you Attend:

The webinar provides a comprehensive overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. The use of cleanrooms to manufacture drug products has been done for years. Microbiological aspects of manufacturing have been incorporated into the manufacturing process. By understanding the microbiological aspect, auditors can understand whether the manufacturing facility is under control. There are international and federal regulations that describe what aspects should be considered during manufacturing.

This webinar will go into detail on those regulations and how they apply to pharmaceutical and biopharmaceutical manufacturing.

Areas Covered in the Webinar:

  • International regulations (ISO)
  • Federal regulation (FDA, USP)
  • Room classifications and how applied to manufacturing
  • Auditing company environmental programs for effectiveness
  • Reviewing of documents in relation to microbial aspects
  • Sources of common microorganisms
  • Identify root causes for many microbiological excursions

Who Will Benefit:

This training webinar has been designed for the following personnel in pharmaceutical, biopharmaceutical companies:

  • Quality assurance personnel
  • Quality control personnel
  • Microbiology professionals
  • Validation
  • Manufacturing
  • Quality system auditors
  • Warehouse managers
  • Facilities/maintenance
  • Regulatory and compliance management
Instructor Profile:
Carl Patterson

Carl Patterson
QA Team Lead, Bachem

Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance Professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However, his avid interest in all things biology, microbiology, and biochemistry officially began when he served in the U.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse.

Furthermore, Carl holds various degrees and certifications, including an M.S. in Biomedical Quality Systems from San Diego State University, a B.S. in Microbiology from the University of Texas, and Specialized Certificates in QA/QC & Biotechnology from UCSD.

Topic Background:

The microbial aspect of pharmaceutical/biopharmaceutical manufacturing is a key component of the overall manufacturing process. Understanding this component is vital in ensuring a pharmaceutical product meets the expectations of a regulatory agency. If this component of the manufacturing process is not well understood, consequences to be harmful to the patient and subsequently the company producing the product.

Follow us :
FDA's Regulation of Regenerative Medicine including Stem Cell Treatments
Designing and Sustaining New and Existing Product Stability Testing Program

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

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed
    Loading