Introduction to Quality

This module will provide the student with knowledge of quality management systems and GMP. The student will be able to apply these GMP practices in regulated industries.

1. Interpret the regulations, guidelines and standards for a GMP facility and apply the fundamentals of GMP (Good Manufacturing Practice).

2. Differentiate between QA and QC in the context of a regulated environment.

3. Create SOP's (Standard Operating Procedures) and other technical documents using regulatory guidelines.

4. Articulate and report quality non-conformances effectively including using the CAPA process.

5. Explain the purpose and value of Risk Management, Equipment and Computerized System Validation and Change Control.

6. Discuss the role of Pharmacopeias in an analytical laboratory.