The FDA Aseptic manufacturing guidance

Webinar : April 13th, 1:00 PM - 2:00 PM EDT

If the FDA Aseptic manufacturing guidance applies to your business, then we have the right module for you in this webinar.

This session will help pharmaceutical manufacturing companies understand what actions are needed to prevent a product being destroyed or a recall due to an aseptic processing problem. Understand;

• What the AP guidance document is used for
• The concepts described in the document
• The proper controls to prevent the problems

Why Should You Attend:

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.

Areas Covered In This Webinar:

• 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
• Validation of Aseptic Processes
• Examples on how the concepts outlined in the Aseptic Processing Guidance document can be implemented

Speaker:

Instructor Carl Patterson has completed 12 years in the biotechnology, pharmaceutical manufacturing, and quality fields.

At AtoZ Compliance, we focus on our core values - quality, expertise, and customer experience which are the foundation of our business. We believe that our up to date training programs will help you grow and succeed in your business.

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