FDA Aseptic Guidance
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.
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.
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, many of the failures related to aseptic processing can be eliminated.
- A brief history of the reason why the Aseptic processing guidance document is important
- A brief overview of the Aseptic Processing Guidance Document – Sep 2004
- Reviewing the concepts outlined in the Aseptic Guidance document and ways to implement the concepts described in the guidance document
- Examples of how the concepts outlined in the Aseptic Processing Guidance document can be implemented
Course Level - Intermediate
Who Should Attend
- Quality Assurance
- Quality Control