Online Seminar 2019 - Live Webinar Understanding the FDA Compounding Pharmacies Guidance Document

Overview
The process of aseptic filling of final drug products provide a excellent reference when it comes putting the proper procedures and controls into place for preventing many of the insanitary conditions outlined in the guidance document. By understanding how final drug product is aseptically filled, Compounding Pharmacies can implement many of the controls used. The guidance reference the industry uses to process products aseptically is the Aseptic Processing Guidance Document –Sept 2004. By reviewing and implementing the concepts in this document, many of the examples of insanitary conditions outline the proposed guidance document can be eliminated.
Session Highlights
Brief history of reason why the Compounding Pharmacy Guidance document is being implemented.
Brief overview of the Aseptic Processing Guidance Document – Sep 2004.
Reviewing the Aseptic Guidance document and how it implies to the insanitary conditions described in the proposed guidance document.
Examples on how the concepts outlined in the Aseptic Processing
Who will benefit
Employess
Supervisors
Managers involved in compounding drug products.
Quality personnel involved with reviewing procedures, batch records, and results associated with aseptically compounding drug products
Speaker Profile
Carl Patterson is a seasoned Pharmaceutical Manufacturing, Quality Control, 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.
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.