Speaker Profile
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.
To date, Carl has now garnered over two decades’ worth of extensive hands-on expertise. Currently, he is the Chief Consultant of his very own consultant business called aseptic-process.net, where he specializes in the aseptic processing of pharmaceutical products in the pharmaceutical manufacturing sector. Recently, he is in the process of creating webinars so he can share pertinent information about pharmaceutical manufacturing from a microbiological perspective.
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.

Carl Patterson
July 28 2022
02 : 00 PM EST
60 Minutes
GMP Audits: Tools and Techniques
The extreme criticality of GMP audits and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal and external GMP audits in order to find and correct areas where sites are not in full compliance with the GMP regulations before an FDA audit occurs. By providing proper tools and techniques to be used during a GMP audit. The auditor can begin to understand the areas wh..

Carl Patterson
August 18 2022
02 : 00 PM EST
60 Minutes
Sterilization of Pharmaceutical Products and Medical Devices
This topic will discuss the methods of sterilization to be used on medical devices and pharmaceutical products. Understanding the regulations pertaining to the sterilization of products will help to decide on a method to use for your product. The advantages and disadvantages of each will be discussed. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the pr..

Carl Patterson
September 08 2022
02 : 00 PM EST
60 Minutes
Objectionable Microorganisms in Pharmaceutical Manufacturing
Objectionable microorganisms are considered if discovered, harmful to the patient. By identifying and controlling these microorganisms, then putting the appropriate controls place early in the pharmaceutical manufacturing or medical device manufacturing process problems in the patient can be prevented. This webinar will review the regulations pertaining to objectionable microorganisms, agency expectations, ..

Carl Patterson
October 20 2022
02 : 00 PM EST
60 Minutes
Auditing for Microbiological Aspects in Pharmaceutical Manufacturing
The seminar 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 fa..

Carl Patterson
November 10 2022
03 : 00 PM EST
60 Minutes
FDA Aseptic Guidance
Aseptically processing the final drug product is a crucial step in the drug manufacturing process.Failures related to the aseptic processing of a final drug product are detrimental to patients. In many cases, once a failure is discovered, the drug product is considered unfit for use and may be destroyed. By understanding and implementing the concepts described in the Aseptic Guidance document, – Sep 2004, m..

Carl Patterson
December 08 2022
02 : 00 PM EST
60 Minutes
Environmental Monitoring Investigations
This seminar will provide an overview of environmental monitoring investigations and tools to complete an investigation. Environmental monitoring is the method by which clean rooms are known to maintain a certain level of cleanliness. The methods by which clean rooms are monitored are through viable and non-viable testing. Through this testing, a room may demonstrate that it is out of control. This seminar ..

Contamination Controls for Non-Sterile Drug Product Manufacturing Facilities
This presentation is intended as an introductory overview of current industry best practices for minimizing the risk of non-sterile drug product contamination during the manufacturing process. A brief overview of the primary regulatory requirements and industry standards will be presented, (FDA, EU, ISO, ICH, USP, PDA, USP), followed by presentation and analysis of 3 differing approaches for contamination c..