Auditing for microbiological aspects in pharmaceutical and biopharmaceutical manufacturing

Introduction

Microorganisms can be found in any aspect of pharmaceutical manufacturing, especially, biopharmaceutical manufacturing. Understanding where to look for microorganisms and how these are introduced into your process will provide success when being reviewed by an regulatory agency or auditor. It is not enough to identify the microorganisms in your process, but to understand, how, where, when, and why the microbes are present in your process. These are questions regulatory bodies and 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 and regulatory bodies can understand whether the manufacturing facility is under a state of 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.

Learning Objectives

• International regulations (ISO)
• Federal regulation (FDA, USP)
• Room classifications and how applied to manufacturing

Areas covered in the Webinar

• 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?

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

Speaker : Carl Patterson

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.

Time: 01:00 PM EST| 10:00 AM PST | Duration: 60 Minutes