This webinar will cover in detail the FDA Compounding Pharmacies Guidance and will review the Aseptic Guidance document. It will help Compounding Pharmacies understand what actions are needed in order to prevent insanitary conditions.
The process of aseptic filling of final drug products provide an 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.
Why Should You Attend:
The FDA has recently been cracking down on Compounding Pharmacy facilities due to the fungal meningitis outbreak in 2012 that caused 60 deaths and 750 cases of infection. As a result of this, the Agency is not confident in the ability of Compounding Facilities to maintain a state of control on their facilities and the conditions under which the product is compounded. Many of the insanitary conditions described by the Agency are outlined in this guidance document.The process of aseptic filling of final drug products provide an 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 in the Webinar:
- History of reason why the Compounding Pharmacy Guidance document is being implemented.
- 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 Guidance document can be implemented.
Who Will Benefit:
- Quality Assurance Managers and Directors
- Quality Control Personnel
- Supervisors, and Managers involved in Compounding Drug Products
- Consultants
- Regulatory and Compliance Management
- Regulatory Affairs Professionals
Course Provider
Carl Patterson,
