This is an advanced level course.

Description

Validation of facilities, equipment and critical process steps utilized for the manufacture of biological products is required in order to comply with regulatory requirements from government agencies such as the US Food and Drug Administration. The design and execution of an adequate validation program will assure that the facilities used in manufacturing are appropriately established and maintained conforming to design specifications and the production process is under an appropriate state of control. These elements represent a key contribution to assuring the final quality of the biological product manufactured.

This course presents a detailed discussion of the approaches that a biopharmaceutical company can take in order to implement a validation program that will achieve the ultimate goal of complying with the regulatory requirements for validation in an evolving environment. Examples from real case situations will be used to demonstrate such approaches and to guide participants through lessons learned by experienced practitioners.

What You Will Learn

• An integrated view of the validation efforts required of a biopharmaceutical manufacturer
• Workable approaches for implementing a validation program
• Examples of Validation Master Plan and validation protocol preparation
• The latest trends in FDA regulatory requirements and their relationship to validation
• Strategic thinking skills toward the validation exercises
• How to ask the right questions during validation

Who Should Attend

This course is intended for individuals who are involved with manufacturing, quality functions, engineering, validation, and process development for biological products. Such individuals can be involved with the design and construction of a biopharmaceutical facility, the development, operation, and validation of a bio-manufacturing process, or preparation for licensure.

Schedule