Auditing for Microbiological Aspects of Pharmaceutical Manufacturing

03:00 PM ET | 12:00 PM PT | 02:00 PM CT Duration 60 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 60 Min Live Webinar

"Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance Professional who is based in San Diego, California"

Understand, how, where, when, and why the microbes are in your process

Description


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.
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

  • 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

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

 


Speaker Profile

Carl Patterson, M.S.

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.

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