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Process Validation for Drugs and Biologics

 
  March 24, 2010  
     
 


Complianceonline, Online Web Event
2010-04-22


In this Process Validation learn how to validate a manufacturing process and do it in a reasonable time.

Why Should You Attend:

Every pharmaceutical manufacturing process is a batch process that consists of discrete steps and which require specific equipment and its operation in specific manner for a specific length of time. US Federal Regulations require validation of the manufacturing process for each product sold. Validation consists of establishing which operating parameters are critical to the success of the process and the precise range of operations that will assure consistent and reproducible product quality every time.

Many papers have been written about this subject. Unfortunately, most of these publications are overly complex and serve to confuse more than to be helpful. As one of the few people who were there at the inception of the validation requirement and who served on a Pharmaceutical Manufacturers Association validation advisory committee, this speaker has not only validated processes around the world, but was there when the validation concepts were developed and methodologies were negotiated with FDA. In this webinar, you will learn not only how to validate a manufacturing process, but how to do so in a reasonable period of time.

Areas Covered in the Seminar:
  • Validation overview.
  • Retrospective Validation.
  • Installation Qualification.
  • Operational Qualification.
  • Process Qualification (also known as Process Validation).
  • Cleaning Validation.
  • Specific PV applications for Drugs.
  • Specific PV applications for Biologics.

 

 
 
Organized by: ComplianceOnline
Invited Speakers: James R. Harris, Dr. Harris has over 25 years of senior level pharmaceutical industry experience. Following this and for the past 15 years, he operated a global consulting firm that provided guidance to firms in over 60 countries around the world. One of the services that were highly sought by clients was assistance in conducting clinical trials. He has assisted many firms in designing the trials, writing trial protocols, selecting a CRO to perform the project management, and oversee the trial process.
 
Deadline for Abstracts: Call contact
 
Registration:

Online Event

EVENT INFORMATION

Contact Admin, Phone: +1-650-620-3915 

E-mail: admin@complianceonline.com
 
   
 
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