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Aseptic Processing & Aseptic Techniques

Duration : 60 Minutes

Carl Patterson, MS, SSGB, SSBB,

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 Read more

The seminar provides a comprehensive overview of aseptic processing and aseptic techniques. Many of the drug products manufactured for use are injected into our bodies. By avoiding our first line of defense against infection, any possible source of infection can wreak havoc on our immune systems. In order in insure our safety, these drugs must be produced aseptically, meaning with little to no source of infection. Aseptic processing is the process by which these drugs are produced aseptically. Aseptic techniques are the principles by which aseptic processing is done.

Course Objectives:

• Background information on what is aseptic processing.
• Understand the different methods by which drug products are rendered sterile.
• Understand the controls put into place to insure product sterility
• Describe the interrelationship between the components used for aseptic processing.
• Describe a process flow of aseptic processing.
• Definition of aseptic technique

Course Outline:

• Definition of aseptic processing
• Principles of aseptic processing
• FDA guidance document on aseptic processing, September 2004
• EU Annex 1, sterile manufacturing
• Regulatory expectations
• Definition of aseptic technique
• Principles of aseptic technique

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Aseptic Operators
• Aseptic Sample Handlers
• Quality assurance counterparts
• Pharmaceutical Manufacturing Personnel/Companies
• Contract Manufacturing Personnel/Companies (CMOs)
• Personnel involved with observing aseptic processing operations
• All personnel who work for pharmaceutical manufacturing and contract manufacturing organizations where aseptic processing and technique are required

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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Subject : Aseptic Processing & Aseptic Techniques

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