Understanding the FDA Compounding Pharmacies Guidance Document

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

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

Why the Compounding Pharmacy Guidance document is being implemented

Description

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.

Areas Covered

•       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
•       Results associated with aseptically compounding drug products

Industries who can attend

This 60 minute online course is intended for professionals in the Pharmaceutical and Biopharmaceutical 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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