Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing

6 years ago Posted By : User Ref No: WURUR20673 0
  • Image
  • TypeWebinar
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  • Location Aurora, Colorado, United States
  • Price
  • Date 10-05-2018
Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing, Aurora, Colorado, United States
Webinar Title
Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
Event Type
Webinar
Webinar Date
10-05-2018
Last Date for Applying
10-05-2018
Location
Aurora, Colorado, United States
Organization Name / Organize By
Training Doyens
Organizing/Related Departments
Life Science
Organization Type
Organization/Company
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
All (State/Province/Region, National & International)
Related Industries

Education/Teaching/Training/Development

Biotechnology

Real Estate/Property/Construction

Location
Aurora, Colorado, United States

OVERVIEW

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.

WHY SHOULD YOU ATTEND

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.

AREAS COVERED

  • 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

LEARNING OBJECTIVES

  • Provide background information on what microbiological aspects to audit for.
  • What international regulations should be referenced.
  • ISO classification of rooms and how it should be applied
  • Product bioburden and why bioburden is important.
  • Validation and qualification of bioburden and manufacturing suites.
  • Key sources of microorganisms and why this is important
  • What the source means in terms of root cause

WHO WILL BENEFIT

All personnel who work for pharmaceutical manufacturing and contract manufacturing organizations where microbiological aspects are monitored and reported.

For more detail please click on this below link:

https://bit.ly/2HuVXcT

 

Email: [email protected]

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

 

 

Others Details

Understand the procedure of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing.

Registration Fees
Available
Registration Fees Details
Live Session for one participant $199 Corporate Live Session Group – Max 10 Participants from one location. $549 Recorded Session Get unlimited access to the link for six months. $219 Training DVD or USB Flash Drive MP3 files, PDF presentation and reference manual will be delivered on a CD $399 Super Combo Offer 1 Live and Recorded webinar $329 Super Combo Offer 2 Live and Training CD $499
Registration Ways
Email
Phone
Website
Other
Address/Venue
  Training Doyens 26468 E Walker Dr,Aurora, Colorado  Pin/Zip Code : 80016-6104
Landmark
Colorado
Official Email ID
Contact
Training Doyens

Training Doyens 26468 E Walker Dr,Aurora, Colorado

[email protected]

   7209961616