M4 - Objectives and Pre-Task

77 unread replies.5151 replies.

OBJECTIVES

At the end of the module, the student should be able to:

1. Demonstrate understanding on process validation.

2. Be familiar with the regulatory guidelines and technical references for equipment, analytical method,
process and cleaning validation

Have an idea on how  a process validation is conducted in this image for Food and Drug administration
(FDA) compliance:

PRE - TASK

Aside from the word tedious and challenging ,  how will you describe  a process validation in one word or
phrase? Explain briefly your thoughts. Type your answer on the reply portion.