Aseptically processing final drug product is a crucial step in the drug manufacturing process. Failures related to 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. The process of aseptic filling final drug products is not an easy task. The FDA Aseptic Processing Guidance document gives guidance when it comes putting the proper procedures and controls into place for preventing harm to a patient related to aseptic processing. By understanding how final drug product is aseptically processed, pharmaceutical companies can implement many of the controls described in the FDA Guidance Document.
Agenda
- Brief history of reason why the Aseptic processing guidance document is important,
- 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 on how the concepts outlined in the Aseptic Processing Guidance document can be implemented.
Speakers
Carl Patterson,
Who Should Attend
- Quality Assurance Managers and Directors
- Quality Control Personnel
- Supervisors
- and Managers involved in Compounding Drug Products
- Consultants
- Regulatory and Compliance Management
- Regulatory Affairs Professionals
