Process Robustness: The New FDA Paradigm

In this training program, attendees will learn how process robustness tools and metrics can be utilized to enhance process understanding and control. The new FDA paradigm is shifting to the expectation that organizations certified by other standards such as ISO and EFfCI demonstrate process robustness. 

Why Should You Attend:

Process robustness is not a new concept; however, it may be new to organizations that are not required to perform validation. There is more to a robust process than having a dosage form pass final specifications. Robustness cannot be tested into a product; rather, it must be incorporated into the design and development of the product.

Who Will Benefit:

Sr. Directors/Directors

QA Specialists (Senior Level)

Compliance Professionals

Quality System Consultants

Production Management

Technical Services Managers

Instructor Profile:

Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. Her expertise is in defining, implementing, and maintaining quality management systems that are cohesive and properly interact with all areas of the organization.

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/process-robustness-the-new-fda-paradigm-webinar-training-703990-prdw?channel=sciencedz