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Subscribe NewsletterProcess Validation for Drugs and Biologics
Product Id
:
600117
Overview: Every pharmaceutical manufacturing process is a batch process that consists of discrete steps. Each of these steps involves the use of specific equipment and its operation in a specific manner for a specific length of time.
Validation consisted 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. When validation is performed as intended, the manufacturing process will be specifically defined and will consistently result in the desired quality product. This should be so reproducible that testing of the finished product is not really necessary - - - the product was made according to a validated process and will always be of the desired quality.
Validation consisted 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. When validation is performed as intended, the manufacturing process will be specifically defined and will consistently result in the desired quality product. This should be so reproducible that testing of the finished product is not really necessary - - - the product was made according to a validated process and will always be of the desired quality.
Why should you attend:
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 Session:
- 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
Who Will Benefit:
- Validation technicians
- Managers and Directors from Manufacturing and Quality Departments
- Validation Managers, Directors